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JCN Newswire

Eisai Files Marketing Authorization Application for Anti-Amyloid-Beta Protofibril Antibody Lecanemab for Early Alzheimer’s Disease in Japan

January 16, 2023

TOKYO and CAMBRIDGE, Mass., Jan 16, 2023 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has submitted a marketing authorization application for lecanemab (Brand Name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril(1) antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia (collectively known as early AD) with confirmed presence of amyloid pathology in the brain to the Pharmaceuticals and Medical Devices Agency (PMDA).This application is based on the results of the Phase III Clarity AD study and Phase IIb clinical study (Study 201), which demonstrated the lecanemab treatment showed a reduction of clinical decline in early AD. Prior to submitting this application, Eisai utilized the prior assessment consultation system of PMDA, with the aim of shortening the review period for lecanemab. In the Clarity AD study, lecanemab treatment resulted in highly statistically significant results, reducing clinical decline on the global cognitive and functional scale as the primary endpoint (CDR-SB(2): Clinical Dementia Rating-Sum of Boxes) as early as six months, and over time across all time points. All key secondary endpoints also showed highly statistically significant results. Especially, treatment with lecanemab showed a statistically significant reduction in amyloid plaque burden at all timepoints starting at 3 months in the amyloid PET study and statistically significantly slowed decline of activities of daily living on ADCS MCI-ADL(3). The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.In November 2022, the results of Clarity AD study were presented at the 15th Clinical Trials on Alzheimer's Disease (CTAD) conference and simultaneously published in the peer-reviewed medical journal the New England Journal of Medicine(New Window).In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration (FDA) on January 6, 2023. On the same day, Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway. In Europe, Eisai submitted marketing authorization application (MAA) to the European Medicines Agency (EMA) on January 9, 2023. In China, Eisai initiated submission of data for BLA to the National Medical Products Administration (NMPA) of China in December 2022.Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully gain health authority approval.For more information, visit www.eisai.com/news/2023/news202307.html.MEDIA CONTACT:Eisai Co., Ltd.Public Relations DepartmentTEL: +81-(0)3-3817-5120Eisai Inc. (U.S.)Libby Holman+ 1-201-753-1945Libby_Holman@eisai.com INVESTOR CONTACT:Eisai Co., Ltd.Investor Relations DepartmentTEL: +81-(0)03-3817-5122 Copyright 2023 JCN Newswire. All rights reserved. (via SEAPRWire)

JCN Newswire

Soligenix On Track to Deliver Important Front-Line Treatment to US Market in 2024

January 15, 2023

NEW YORK, NY, Jan 16, 2023 - (JCN Newswire via SEAPRWire.com) - PCG Digital -- Soligenix, Inc. (Nasdaq: SNGX), a late-stage biopharmaceutical company, is on track to deliver a safe and effective front-line treatment to a community of patients living with a rare, chronic cancer.[Image: Soligenix, Inc.]Cutaneous T-cell lymphoma (CTCL) is difficult to treat and remains an area of significant unmet medical need, with a very limited number of safe treatment options available. Soligenix estimates the potential worldwide market for its therapeutic, HyBryte(TM)(synthetic hypericin), to be in excess of $250 million for the treatment of CTCL.Soligenix accomplished a number of key milestones in 2022, but difficult global market conditions meant the company was unable to achieve the stock price gains it had hoped for.Soligenix has announced its intention to seek shareholder approval for a reverse stock split next month.Watch the video interview with Soligenix President and Chief Executive Officer, Dr. Christopher Schaber on Jan 12 to hear more: https://youtu.be/YLh2M_8DsUE.Q: Why did you decide a reverse stock split was the best course of action for Soligenix, and why now?A: The primary goal of a reverse stock split will be to maintain Soligenix's Nasdaq listing. As we wait for a potential NDA approval from the FDA, and work towards the US launch of HyBryte, it is a critical time to remain a Nasdaq listed company.A reverse stock split may also serve to increase the trading price of our common stock, making Soligenix a more attractive value proposition to a broader range of investors, including institutional investors. It also has the potential to support any future capital-raising efforts.We were in discussions with Nasdaq during 2022 to request additional time to regain compliance and did not take pursuit of this action lightly. We waited as long as we could to ensure we had time to announce all of our key milestones during the year, most notably the submission of our new drug application (NDA) for HyBryte(TM) in the treatment of CTCL, which has a global market potential of approximately $250 million.Q: How will remaining on the Nasdaq create opportunities for Soligenix shareholders?A: We see significant potential upside for Soligenix's shareholders. Increasing our trading price will, we believe, encourage new investor interest in Soligenix, potentially resulting in greater liquidity for our shareholders. Institutions are often reluctant to buy stocks with a price below a certain threshold, and a higher share price would increase Soligenix's marketability, trading volume and liquidity of our common stock. Similarly, we may see renewed interest from analysts and brokers that typically avoid following or recommending companies with low stock prices.Our Board of Directors has thoroughly reviewed Soligenix's position and options and has approved the reverse stock split as being in the company's best interests.Q: Soligenix has indicated it is expecting to achieve some significant milestones in 2023. Can you expand on that?A: Soligenix is expecting to achieve a number of important milestones in 2023. We are anticipating the FDA's acceptance of our NDA for review in the first half of the year, and later in the year, the potential NDA approval in the US of HyBryte.In Q4 2022, Soligenix was invited by the Biomedical Advanced Research and Development Authority (BARDA) to submit a full contract proposal for the development of single-vial, adjuvanted, heat stable subunit vaccines to prevent filovirus infection. We are expecting to hear from BARDA about this potential multi-year, multi-million dollar contract award for our vaccine candidates, SuVax(TM) and MarVax(TM), against Ebola and Marburg viruses.Also, in Q4 2022, Soligenix initiated a Phase 2 clinical trial of SGX302 (synthetic hypericin) for the treatment of mild-to-moderate psoriasis. We are excited to expand synthetic hypericin's development into different cutaneous T-cell diseases such as psoriasis, as we execute on our long-term strategy to enhance the value of this unique compound. Psoriasis is a widespread unmet medical need, affecting as many as 7.5 million people in the U.S. and between 60 and 125 million people worldwide. We expect to report results from the study in the second half of 2023.Q: Following FDA approval, what will be next for HyBryte?A: Our NDA for HyBryte has been granted FDA orphan drug and fast track designations, due to its potential as a safe and effective front-line treatment for CTCL. We are anticipating potential approval in the second half of 2023 and we are targeting the first quarter of 2024 for our US launch.Additionally, we announced in September 2022 that the FDA had awarded a $2.6 million Orphan Products Development grant for an expanded study of HyBryte(TM) in the treatment of CTCL, including in the home use setting. The home use setting is a very important growth area for us, so we are very excited that this investigator-initiated study will begin in the first half of this year.Our goal remains to deliver an innovative first-in-class therapy to the CTCL community, and we believe we are on track to achieve this important goal.For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com, subscribe to the YouTube channel @Soligenix, and follow on LinkedIn and Twitter at Soligenix_Inc.- YouTube: https://www.youtube.com/@SoligenixInc- LinkedIn: https://www.linkedin.com/company/soligenix-inc-/- Twitter: https://twitter.com/Soligenix_IncPCG DigitalE: info@pcgadvisory.comT: +1-646-863-6341DisclaimerThis communication was produced by PCG Digital Holdings, LLC, an affiliate of PCG Advisory Inc., (together "PCG"). PCG is not a registered or licensed broker-dealer nor investment adviser. No information contained in this communication constitutes an offer to sell, a solicitation of an offer to buy, or a recommendation of any security. PCG may be compensated by respective clients for publicizing information relating to its client's securities. See www.pcgadvisory.com/disclosures. Copyright 2023 JCN Newswire. All rights reserved. (via SEAPRWire)

ACN Newswire

AJG Publishes Data from HighTide Therapeutics’ Phase 2 Study of HTD1801 Treatment in Primary Sclerosing Cholangitis

November 17, 2022

ROCKVILLE, MD and SHENZHEN, CHINA, Nov 17, 2022 - (ACN Newswire via SEAPRWire.com) - HighTide Therapeutics, Inc. ("HighTide"), a globally integrated clinical-stage biopharmaceutical company developing novel multifunctional therapies for metabolic and digestive diseases, today announced the publication of the results of their Phase 2 study of HTD1801 in adults with primary sclerosing cholangitis (PSC) in the American Journal of Gastroenterology. (https://journals.lww.com/ajg/Fulltext/2022/11000/A_Randomized,_Dose_Finding,_Proof_of_Concept_Study.22.aspx)This study met the primary endpoint and multiple key secondary endpoints, demonstrating the safety and efficacy of HTD1801 in treating PSC. Serum alkaline phosphatase (ALP) is a key biomarker of PSC disease severity. Data show that compared to placebo, both low and high doses of HTD1801 treatment could significantly reduce serum ALP levels. In addition, HTD1801 significantly reduced alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT), further supporting the beneficial effects of HTD1801 in treating PSC. HTD1801 was shown to be safe and well tolerated at the doses studied in PSC patients. No severe adverse event related to HTD1801 treatment occurred.Professor Kris Kowdley, M.D., Director, Liver Institute Northwest and lead investigator, said, "There is a significant unmet medical need in treatment for PSC. The improvements in ALP we observed in this study, along with the excellent safety profile of HTD1801, are promising. In addition, the results of this study lay the foundation for future studies that will potentially prove the significant role of HTD1801 in the treatment of PSC."Dr. Liping Liu, Founder and Chief Executive Officer of HighTide Therapeutics, said, "We are pleased to share the news of this publication. The results of this study encourage us to further study HTD1801's effects in treating PSC. We believe the long-term treatment of HTD1801 will lead to more clinical benefits for patients with PSC, who suffer with a disease with no effective therapy until today."About Primary Sclerosing CholangitisPrimary sclerosing cholangitis (PSC) is a chronic, progressive liver disease characterized by progressive inflammation and fibrosis of the intra-and/or extra-hepatic bile ducts, resulting in multifocal bile duct strictures. Most patients eventually have liver failure and cirrhosis, and their risk of malignancy significantly increases. PSC is strongly associated with inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease. The accumulating evidence from various studies continues to strengthen the hypothesis that the gut microbiota plays a central role in the pathogenesis and progression of PSC. Until today, there is no approved therapy for PSC. As the fifth leading indication for liver transplantation in the U.S., PSC is a disease with significant unmet medical needs.About HighTide TherapeuticsHighTide is a globally integrated clinical-stage biopharmaceutical company focusing on the discovery and development of novel multifunctional therapies for metabolic and digestive diseases with significant unmet medical needs. The company's lead drug candidate, HTD1801, is a first-in-class new molecular entity, currently in clinical development for the treatment of type 2 diabetes (T2DM), nonalcoholic steatohepatitis (NASH), severe hypertriglyceridemia (SHTG), and primary sclerosing cholangitis (PSC). HTD1801 has received Fast Track designation from the U.S. FDA for both NASH and PSC, as well as Orphan Drug designation for PSC. In China, HTD1801 has been included in the National Major New Drug Innovation Program. For more information, please visit www.hightidetx.com.ContactJeffrey Daoir@hightidetx.com+1-650-580-3872 Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

American Journal of Gastroenterology Publishes Data from HighTide Therapeutics’ Phase 2 Study of HTD1801 Treatment in Primary Sclerosing Cholangitis

November 16, 2022

ROCKVILLE, MD and SHENZHEN, CHINA, Nov 16, 2022 - (ACN Newswire via SEAPRWire.com) - HighTide Therapeutics, Inc. ("HighTide"), a globally integrated clinical-stage biopharmaceutical company developing novel multifunctional therapies for metabolic and digestive diseases, today announced the publication of the results of their Phase 2 study of HTD1801 in adults with primary sclerosing cholangitis (PSC) in the American Journal of Gastroenterology.This study met the primary endpoint and multiple key secondary endpoints, demonstrating the safety and efficacy of HTD1801 in treating PSC. Serum alkaline phosphatase (ALP) is a key biomarker of PSC disease severity. Data show that compared to placebo, both low and high doses of HTD1801 treatment could significantly reduce serum ALP levels. In addition, HTD1801 significantly reduced alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT), further supporting the beneficial effects of HTD1801 in treating PSC. HTD1801 was shown to be safe and well tolerated at the doses studied in PSC patients. No severe adverse event related to HTD1801 treatment occurred.Professor Kris Kowdley, M.D., Director, Liver Institute Northwest and lead investigator, said, "There is a significant unmet medical need in treatment for PSC. The improvements in ALP we observed in this study, along with the excellent safety profile of HTD1801, are promising. In addition, the results of this study lay the foundation for future studies that will potentially prove the significant role of HTD1801 in the treatment of PSC."Dr. Liping Liu, Founder and Chief Executive Officer of HighTide Therapeutics, said, "We are pleased to share the news of this publication. The results of this study encourage us to further study HTD1801's effects in treating PSC. We believe the long-term treatment of HTD1801 will lead to more clinical benefits for patients with PSC, who suffer with a disease with no effective therapy until today."About Primary Sclerosing CholangitisPrimary sclerosing cholangitis (PSC) is a chronic, progressive liver disease characterized by progressive inflammation and fibrosis of the intra-and/or extra-hepatic bile ducts, resulting in multifocal bile duct strictures. Most patients eventually have liver failure and cirrhosis, and their risk of malignancy significantly increases. PSC is strongly associated with inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease. The accumulating evidence from various studies continues to strengthen the hypothesis that the gut microbiota plays a central role in the pathogenesis and progression of PSC. Until today, there is no approved therapy for PSC. As the fifth leading indication for liver transplantation in the U.S., PSC is a disease with significant unmet medical needs.About HighTide TherapeuticsHighTide is a globally integrated clinical-stage biopharmaceutical company focusing on the discovery and development of novel multifunctional therapies for metabolic and digestive diseases with significant unmet medical needs. The company's lead drug candidate, HTD1801, is a first-in-class new molecular entity, currently in clinical development for the treatment of type 2 diabetes (T2DM), nonalcoholic steatohepatitis (NASH), severe hypertriglyceridemia (SHTG), and primary sclerosing cholangitis (PSC). HTD1801 has received Fast Track designation from the U.S. FDA for both NASH and PSC, as well as Orphan Drug designation for PSC. In China, HTD1801 has been included in the National Major New Drug Innovation Program. For more information, please visit www.hightidetx.com.ContactJeffrey Daoir@hightidetx.com+1-650-580-3872American Journal of Gastroenterologyhttps://tinyurl.com/mr3wyhu6 Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

ACN Newswire

Zhaoke Ophthalmology’s Partner Vyluma Announces Positive Results from Phase III CHAMP Study of NVK002 for Treatment of Myopia Progression in Children

October 28, 2022

HONG KONG, Oct 28, 2022 - (ACN Newswire via SEAPRWire.com) - Zhaoke Ophthalmology Limited ("Zhaoke Ophthalmology" or "the Company", SEHK: 6622), a leading ophthalmic pharmaceutical company dedicated to the research, development, manufacturing and commercialization of treatments that address significant unmet medical needs, is pleased to announce that the Company's partner Vyluma, Inc. ("Vyluma") , a biopharmaceutical company developing multiple assets for the treatment of refractive errors, announced top-line results from its Phase III CHAMP (Childhood Atropine for Myopia Progression) clinical study. Analysis of this multi-center, international study, performed after three years of treatment and follow up, demonstrates strong safety and efficacy for NVK002 as a potential treatment for the progression of myopia in children. The results were shared on 27 October in an oral presentation at the American Academy of Optometry annual meeting in San Diego, CA."CHAMP is the largest and longest placebo-controlled, prospective pediatric myopia study conducted to date and we are very encouraged by the results from the first stage," said Navneet Puri, PhD, Founder, Chairman and Chief Executive Officer, Vyluma. "Myopia is a growing global epidemic that can have serious consequences for the vision of millions of children later in life, yet there are no currently available, regulatory approved pharmaceutical treatments. While we are conducting analyses of the data to assess the full results, the top-line results represent a significant landmark in myopia management and signify a potential new and more hopeful era on the horizon."Developed by Vyluma, NVK002 is a proprietary, investigational, low-dose, preservative-free atropine eye drop administered nightly. NVK002 leverages what is known about a well-characterized therapeutic agent, atropine, in a new low-dose, preservative-free formulation to help address the urgent need for pharmacological control of myopia. CHAMP is a three-arm, randomized, double-masked, placebo-controlled Phase III clinical study conducted across the U.S. and Europe in nearly 600 children and adolescents aged three to seventeen years at enrollment. The study consists of two stages: a completed three-year treatment period to evaluate the safety and efficacy of NVK002, after which enrolled patients were re-randomized for a masked, ongoing one-year treatment period to characterize cessation of therapy. NVK002 at a dose of 0.01% atropine achieved statistically significant and clinically meaningful differences from placebo in every key outcome measure, including responder analysis, mean change from baseline in Spherical Equivalent Refraction (SER), and mean change from baseline in axial length at month 36. NVK002 at a dose of 0.02% demonstrated efficacy at several time points, including a statistically significant mean change in axial length compared to placebo at 36 months. Responder analysis was not statistically significant at month 36. NVK002 at both doses demonstrated strong safety and tolerability which were comparable to placebo. There were no ocular serious adverse events (SAEs) and the incidences of non-ocular SAEs and discontinuations due to non-ocular SAEs were similar across treatment groups. The most common ocular adverse events were hyperemia, photophobia, allergic conjunctivitis, eye pruritis, and eye irritation."Myopia is a serious condition that impacts the vision of 30% of the world's population today and is expected to impact an estimated 5 billion people by 2050. The earlier myopia is addressed, the better,"1,2 said Karla Zadnik, OD, PhD, FAAO, lead investigator and Glenn A. Fry Professor of Optometry and Physiological Optics and Dean at The Ohio State University College of Optometry. "The CHAMP study shows us that Vyluma's novel formulation of low-dose atropine can make a clinically meaningful difference in treating children with myopia. This new evidence increases our scientific understanding of the safe and effective ways we can tackle this growing global burden."Vyluma has partnered with Laboratories Thea and Zhaoke Ophthalmology for commercialization of NVK002. Thea, the leading independent European pharmaceutical group in ophthalmology, will be responsible for the commercialization of NVK002 in Europe, and for the registration and commercialization in Canada, Mexico, and selected South American countries. Zhaoke Ophthalmology, a leading ophthalmic pharmaceutical company, will be responsible for the clinical development and commercialization of NVK002 in Greater China, South Korea, and certain select countries in Southeast Asia (Brunei, Burma, Cambodia, Timor-Leste, Indonesia, Laos, Malaysia, the Philippines, Singapore, Thailand, and Vietnam)."In China, hundreds of millions of children and adolescents suffer from myopia. We are excited by the encouraging data in the U.S. and Europe. This adds to the evidence for the NVK002 NDA submission to the Chinese regulator. Our intention is to bring this drug to market as soon as possible and these results take us one step closer in our mission to transform visual health in China," said Dr. Li Xiaoyi (Benjamin), Chairman of the Board of Directors, Executive Director and CEO, Zhaoke Ophthalmology.Vyluma plans to submit a New Drug Application for NVK002 to the U.S. Food and Drug Administration (FDA) as early as Q1 2023. If approved by the FDA, NVK002 would be a first-in-class, clinically proven pharmaceutical agent for the treatment of myopia progression in children. For more information about Vyluma and NVK002, please visit www.vyluma.com.About MyopiaMyopia is a serious and irreversible condition that causes loss of vision due to eye elongation. It is considered to be a growing global epidemic that will affect roughly half the world's population by 2050.1 Myopia prevalence is accelerating because of increased exposure to close work on digital screens and reduced time outdoors, both of which have been exacerbated by COVID-19.3 If left untreated, childhood myopia increases the risk of vision loss and eye complications later in life, due to cataracts, glaucoma and retinal disease.4 Myopia progresses most rapidly between the ages of 5 and 15 when eyes are developing quickly.5 Vision correction with single vision contact lenses and spectacles does not slow myopia progression, leaving children at risk of serious consequences later in life.6,7,2About Vyluma, Inc.Vyluma is a development-stage biopharmaceutical company with a focus on pharmaceutical treatments for refractive errors of the eye. Vyluma has a robust pipeline of assets in various stages of development which address important unmet treatment needs of patients with refractive errors or eye pain. Vyluma itself is a subsidiary of Nevakar Inc., a holding company whose subsidiaries are also engaged in developing products for the injectable markets. For additional information please visit www.vyluma.com.About Nevakar Inc.Nevakar Inc. is a fully integrated privately held, commercial-stage biopharmaceutical company with an extensive portfolio of products in the ophthalmic and injectable areas. Founded in 2015, and headquartered in Bridgewater, New Jersey, the Company is focused on developing and commercializing innovative products to address unmet medical needs, thereby improving patients' quality of life and healthcare outcomes. Nevakar utilizes the 505(b)(2) regulatory pathway, along with its proven expertise in the development of novel and proprietary sterile pharmaceutical products to identify, develop, and obtain regulatory approval for its products. Additional information is available at www.nevakar.com.About Zhaoke OphthalmologyFounded in 2017, Zhaoke Ophthalmology (SEHK: 6622) is a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacturing and commercialization of therapies that address significant unmet medical needs in the world. The company was listed on the Main Board of the Hong Kong Stock Exchange on 29 April 2021. Zhaoke Ophthalmology has a comprehensive drug portfolio of innovative and generic treatments covering six major eye diseases across both the front and back of the eye. Many of the drugs are being produced in its state-of-the-art and fully functional development and production facility in Nansha, Guangzhou.Zhaoke Ophthalmology is focusing on advancing towards the goal of product commercialisation, and achieving the objective of improving visual health in China through scientific research as soon as possible.Through its ambitious growth strategy, including partnering with domestic and international pharmaceutical companies, Zhaoke Ophthalmology's goal is to become a leader in ophthalmology in the world. For more information, please visit: www.zkoph.com Media Contact:Artemis Associates Diana Footitt, CEOM: +852 9183 0667E: diana.footitt@artemisassociates.com Bowen Chui, DirectorM: +852 9783 0643E: bowen.chui@artemisassociates.comIris Pei, DirectorM: +86 15000 465 016E: iris.pei@artemisassociates.com References1. Holden, B. A., Fricke, T. R., Wilson, D. A., Jong, M., Naidoo, K. S., Sankaridurg, P., Wong, T. Y., Naduvilath, T. J., & Resnikoff, S. (2016). Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology, 123(5), 1036-1042. https://doi.org/10.1016/j.ophtha.2016.01.006.2. Sankaridurg, P., Tahhan, N., Kandel, H., Naduvilath, T., Zou, H., Frick, K. D., Marmamula, S., Friedman, D. S., Lamoureux, E., Keeffe, J., Walline, J. J., Fricke, T. R., Kovai, V., & Resnikoff, S. (2021). IMI Impact of Myopia. Investigative Opthalmology & Visual Science, 62(5), 2. https://doi.org/10.1167/iovs.62.5.2.3. Rusnak, S., Salcman, V., Hecova, L., & Kasl, Z. (2018). Myopia Progression Risk: Seasonal and Lifestyle Variations in Axial Length Growth in Czech Children. Journal of Ophthalmology, 2018, 1-5. https://doi.org/10.1155/2018/5076454.4. Ritchey, O. E. D., PhD. (2020, September 18). Myopia Increases the Risk of Serious, Sight-Threatening Eye Disease. Review of Myopia Management. https://reviewofmm.com/myopia-increase-the-risk-of-serious-sight-threatening-eye-disease/.5. Verkicharla, P. K., Kammari, P., & Das, A. V. (2020). Myopia progression varies with age and severity of myopia. PLOS ONE, 15(11), e0241759. https://doi.org/10.1371/journal.pone.0241759.6. Deere, K., Williams, C., Leary, S., Mattocks, C., Ness, A., Blair, S. N., & Riddoch, C. (2009). Myopia and later physical activity in adolescence: a prospective study. British Journal of Sports Medicine, 43(7), 542-544. https://doi.org/10.1136/bjsm.2008.049288.7. Wolffsohn, J. S., Jong, M., Smith, E. L., Resnikoff, S. R., Jonas, J. B., Logan, N. S., Morgan, I., Sankaridurg, P., & Ohno-Matsui, K. (2021). IMI 2021 Reports and Digest - Reflections on the Implications for Clinical Practice. Investigative Opthalmology & Visual Science, 62(5), 1. https://doi.org/10.1167/iovs.62.5.1. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

ACN Newswire

BPipe Corporation, a Joint Venture Partner of Biopipe Global USA, enters into Agreement with Major Global Food Company to Install 10 m3/day Biopipe Biological Sewage Wastewater Treatment Plant

September 27, 2022

MANILA, Sep 27, 2022 - (ACN Newswire via SEAPRWire.com) - BPipe Corporation, an equity joint venture partner of Biopipe Global USA, enters into an agreement with a major global food company to install a 10 m3/day Biopipe biological sewage wastewater treatment plant.BPipe Corporation is focused on innovative, scalable and disruptive decentralized wastewater treatment and reuse technologies. Its flagship system is the Biopipe STP, which is a highly scalable onsite sludge, odor and chemical free sewage wastewater treatment technology. BPipe is an equity joint venture partner established in the Philippines to pursue both sewage and industrial wastewater treatment opportunities for technologies within our portfolio.According to Mr. Freddie Canta, President of BPipe, "In addition to the sludge free, odor free, and chemical free features of Biopipe technology, the customizable design and flexibility to fit in small spaces were the deciding factors that led to this partnership with BPipe. We are happy that this client will promote environmentally sustainable practices by recycling treated wastewater through our Biopipe system.""Biopipe continues to see strong market interest in the Philippines as customers look to long-term, eco-friendly solutions for a more resilient future," says Ms. Nina Aquino, CMO of Biopipe Global Corp. "We look forward to continuing our support of the country's dedication to cleaner waters and safe sanitation practices."About Biopipe Global CorpBiopipe Global Corp is a wholly owned subsidiary of Lifequest World Corp (OTC Markets: LQWC). Lifequest offers both effluent treatment (ETP) and sewage treatment (STP) solutions. Biopipe has developed a patented 100% sludge-free, chemical-free, odor-free, silent, easy to assemble and install, scalable, low cost, ecological and virtually maintenance-free onsite sewage wastewater treatment system. Our Abrimix ETP solution is a highly efficient and cost-effective industrial wastewater treatment system that is vastly superior to Dissolved Air Floatation (DAF) systems. See www.lifequestcorp.com and www.biopipe.co or contact: info@biopipe.co.About BPipe CorporationBPipe Corporation, a Philippine subsidiary of Biopipe Global Corp, is engaged in sales, marketing, distribution, installation, and maintenance of Biopipe STP, Abrimix ETP, Glanris Media and Goslyn FOG and other technologies through its global partnerships.Philippines ContactName: Mr. Freddie CantaEmail: freddie@biopipe.coPhone: +63 9171393642 Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

ACN Newswire

ATAL’s Award-Winning AMSFS III Granted Patent in Mainland China

September 15, 2022

HONG KONG, Sep 15, 2022 - (ACN Newswire via SEAPRWire.com) - Analogue Holdings Limited (stock code: 1977) together with its subsidiaries (referred to as "ATAL Engineering Group", "ATAL" or the "Group"), a leading electrical and mechanical ("E&M") engineering services provider in Hong Kong, today announced that the China National Intellectual Property Administration ("CNIPA") has granted the Group the utility model patent for its award-winning(1) in-house developed sewage treatment technology "ATAL Multi-Stages Flocculation Sedimentation III" ("AMSFS III"). It further strengthens the Group's extensive portfolio of patents acquired, whilst demonstrating its expertise in and commitment to technological innovation and environmental protection. The utility model patent certificate granted by the China National Intellectual Property Administration.ATAL's in-house developed sewage treatment technology "ATAL Multi-Stages Flocculation Sedimentation III" ("AMSFS III") has been applied in sewage projects in Mainland China.ATAL's in-house developed sewage treatment technology "ATAL Multi-Stages Flocculation Sedimentation III" ("AMSFS III") has been applied in sewage projects in Mainland China.Dr Otto Poon Lok-To, Chairman of ATAL Engineering Group, said, "We are gratified that CNIPA granted us the utility model patent for AMSFS III technology, recognising our cross-border teams' collaborations and the capability of in-house technological development. Despite the established market for traditional sewage treatment systems, we saw a surging demand for easy-to-install systems in remote villages and rural areas. With our highly flexible containerised AMSFS III system, I believe we are well-positioned to capture business opportunities in Mainland China and other countries included in the Belt and Road Initiative. Going forward, we will continue to pursue technological breakthroughs, aiming to strengthen environmental protection and improve quality of life through continuous innovation." Co-designed and built by the Group's Hong Kong and Mainland China teams, while manufactured in the Group's factory in Nanjing, AMSFS III is an all-in-one wastewater treatment system leveraging the latest construction technologies including Building Information Modelling ("BIM"), Modular Integrated Construction ("MiC") and Multi-Trade integrated Mechanical, Electrical, and Plumbing ("MiMEP"). In contrast to the conventional system, where all works must be conducted on-site, AMSFS III, with application of the aforementioned technologies, is prefabricated, installed and tested in the factory. Given that it requires small footprint of less than 50m2, AMSFS III provides greater flexibility while reducing the negative impact on the surrounding environment, such as dust and noise pollution at site. The system is containerised and can be installed underground. On the cost and performance front, the fully automatic system has remote monitoring capability to reduce the number of operators needed, which is highly efficient and saves labour and maintenance costs.AMSFS III has been applied in the Group's sewage projects in Mainland China, making significant contributions to the development of the country's wastewater treatment facilities. In particular, AMSFS III was utilised to remove partial suspended solid and total phosphorus in the Shiwuli River Jinzhai Road Initial Stormwater Reservoir Project located in Hefei city. The system enabled effluent to meet the discharge standard without post-filtration and reduced overall construction costs. The Group also deployed AMSFS III in the upgrade of the wastewater treatment facilities for the area along the Macao River in Anhui province, maintaining the effluent quality to achieve Grade A standard as defined in the "Discharge Standard of Pollutants for Municipal Wastewater Treatment Plants".Going forward, it is expected that small-scale and decentralised sewage treatment plants ("STPs") will be in high demand in remote villages and rural areas. Given its small footprint, AMSFS III will be a good fit for these areas. With the current Five-Year Plan of the People's Republic of China requiring the National Grade A discharge standard of STPs to be implemented under stringent environmental controls, new opportunities will emerge for small-scale and easy-to-transport sewage treatment systems.About ATAL Engineering GroupEstablished in 1977, ATAL Engineering Group ("ATAL") is a leading electrical and mechanical ("E&M") engineering service provider headquartered in Hong Kong, with operations in Macau, Mainland China, the United States and the United Kingdom. Serving a wide spectrum of customers from public and private sectors, ATAL provides multi-disciplinary and comprehensive E&M engineering and technology services in four major segments, including Building Services, Environmental Engineering, Information, Communications and Building Technologies ("ICBT") and Lifts & Escalators. ATAL's parent company, Analogue Holdings Limited, is listed on the Main Board of the Stock Exchange of Hong Kong (Stock Code: 1977).(1) AMSFS III has been awarded the "Innovation and Creativity Award" at "2021-22 Hong Kong Awards for Industries: Innovation and Creativity" Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Sinomab Announces IND Application of SN1011 for the Treatment of Neuromyelitis Optica Spectrum Disorder Approved by NMPA

August 24, 2022

HONG KONG, Aug 24, 2022 - (ACN Newswire via SEAPRWire.com) - SinoMab BioScience Limited ("SinoMab" or the "Company", together with its subsidiaries, the "Group", stock code: 3681.HK), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases, is pleased to announce that, on 23 August 2022, an Investigational New Drug application ("IND", for neuromyelitis optica spectrum disorder ("NMOSD")) for SN1011 was approved by the National Medical Products Administration of China (the "NMPA"). The IND approval would enable the Company to initiate the Phase II/III clinical study in China to evaluate the efficacy and safety of SN1011 for the treatment of NMOSD in China. The planned first patient enrollment is in the first quarter of 2023.SN1011 is the Company's third generation, covalent reversible BTK inhibitor designed for higher selectivity, superior efficacy, and improved safety for the long-term treatment of systemic lupus erythematous ("SLE"), pemphigus ("PV"), multiple sclerosis ("MS"), neuromyelitis optica spectrum disorder("NMOSD") and other rheumatoid or immunological diseases. SN1011 differentiates from existing BTK inhibitors currently available in the market, such as Ibrutinib, in terms of mechanism of action, affinity, selectivity and safety. The Phase I study (first-in-human clinical trial) of SN1011 was conducted in Australia and China in 2019 and completed in July 2021, which has demonstrated good safety and pharmacokinetics profile. Currently, four IND applications of SN1011 for the treatment of SLE, PV, MS and NMOSD have been approved by NMPA respectively. At the same time, the Company is planning an IND submission for MS in the U.S.NMOSD is an autoimmune-mediated inflammatory demyelinating disease of the central nervous system with predominant involvement of the optic nerve and spinal cord. The pathogenesis of NMOSD is mainly associated with aquaporin-4 (AQP4) antibodies and is a separate disease entity from multiple sclerosis, with severe optic neuritis and longitudinal extensive transverse myelitis as the main clinical features. However, the cause of NMOSD is unknown, with a combination of environmental factors such as smoking, low vitamin D levels, EBV infection and genetic susceptibility contributing to the development of the disease. Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: "The IND application of SN1011 for the treatment of NMOSD was accepted by the NMPA at the beginning of June, and approved within three months, fully reflecting the potential of SN1011 as well as the efficient execution of the Company's new drug R&D program. The clinical study for the treatment of NMOSD is the fourth indication of SN1011 approved in China following the approval of IND application for SLE, PV and MS, fully demonstrating the great potential of the innovative BTK inhibitor towards multiple indications in the field of the treatment of autoimmune diseases. Currently, numerous of Company's main candidate products, covering indications in the field of autoimmune diseases, have entered clinical stage gradually. Among which, our flagship product SM03 (Suciraslimab) is approaching the endpoint in its Phase III clinical study for rheumatoid arthritis. As the clinical studies of our key candidates moving forward, we will continue to expand the potential indications of the products, promote the global R&D progress and constantly improve our production facility and expand capacity to enhance our commercialization capability. SinoMab is devoting to becoming a biopharmaceutical company, with R&D headquartered in Hong Kong and production based in Mainland China, with whole industry chain layout from R&D to production as well as a global leader in the innovation of therapeutics for immunological and other debilitating diseases. About SinoMab BioScience LimitedSinoMab BioScience Limited (stock code: 3681.HK) is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The Company's flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis (RA) and is currently in Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-target and first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), pemphigus, non-Hodgkin's lymphoma (NHL), asthma, and other diseases with major unmet clinical needs. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Oculis announces publication of Phase 2 data showing topical eye drops anti-TNFa agent licaminlimab (OCS-02) relieves persistent ocular discomfort in severe dry eye disease

August 23, 2022

LAUSANNE, Switzerland, Aug 23, 2022 - (ACN Newswire via SEAPRWire.com) - Oculis S.A., ('Oculis') a global ophthalmology company developing life-changing treatments to save sight and improve eye care with breakthrough innovations, announces that the results of the double blinded, multicenter and placebo controlled Phase 2 clinical trial assessing the effect of topical licaminlimab (OCS-02) on global ocular discomfort in patients with severe dry eye disease (DED) (NCT02365519) has been published by the Clinical Ophthalmology journal. The publication is accessible on the National Institutes of Health (NIH) website here. ( https://pubmed.ncbi.nlm.nih.gov/35821785/ )The results from the study show that the change from baseline to Day 29 in the global ocular discomfort score, the primary efficacy endpoint, was statistically significantly greater for topical ocular licaminlimab (OCS-02) (-7.9) than for vehicle (-3.6) (90% CI -7.7, -0.8; p = 0.041). The percentage of patients with an improvement in global ocular discomfort score >20 from baseline to treatment day 29, one of the main secondary efficacy endpoints, was statistically greater for licaminlimab (17.9%) compared to vehicle (4.7%) (p=0.018).Licaminlimab (OCS-02) was well tolerated in this study, with no major safety differences between licaminlimab (OCS-02) and vehicle treatment groups, and no increase in intra-ocular pressure was observed. Licaminlimab (OCS-02) is a single-chain antibody fragment (scFv) that binds to and neutralizes the activity of human TNFa, with dual mechanism of action (MoA), anti-inflammation and anti-necrosis. Unlike full-length monoclonal antibodies, scFv fragments can penetrate ocular surface tissues when used as eye drops, due to the smaller size of the molecule giving it the potential to become the first approved topical biologic for DED. Dry Eye is a multifactorial disease in which inflammation rapidly takes on a central role in sustaining the pathological state(1). The global prevalence of DED has been reported at 11.59%(2) , representing approximately 900 million people worldwide. In the US alone, there is currently between 16 million and 49 million people who have dry eye disease(3) . Significant unmet medical needs remain for this large and growing patient population with only 9% of diagnosed patients in the US receiving treatment(4) and despite current options, only 13% of patients are achieving lasting relief(5) .Licaminlimab (OCS-02) is currently being investigated by Oculis in Phase 2 clinical trials for the treatment of dry eye disease and uveitis.Pr Christophe Baudouin, M.D., Professor of Ophthalmology and Chairman of Ophthalmology III in Quinze-vingts National Ophthalmology Hospital, Paris, commented: "There is a true unmet medical need for the development of drugs with new MOA to treat the inflammation involved in the pathogenesis of DED. OCS-02 is certainly one that could fill that gap. As compared to currently available treatment options and other product candidates in the DED pipeline, OCS-02 could play a role in the treatment of the underlying causes of the disease given its anti-inflammatory and anti-necrosis benefits. I certainly look forward to the continued development and approval of OCS-02 in severe dry eye disease as these patients currently have limited treatment options."Riad Sherif, M.D., CEO of Oculis, said: "The Phase 2 data further reinforce our confidence in the potential of OCS-02 as a novel anti-inflammatory treatment for the effective management of Dry Eye Disease, but also for other inflammatory eye diseases. With Phase 2b clinical trials of OCS-02 for the treatment of dry eye disease and uveitis which are planned to start in the coming months, along with on-going Phase 3 clinical trials of OCS-01 in diabetic macular edema and inflammation and pain following ocular surgery and a proof-of-concept (POC) trial of OCS-05 in acute optic neuritis, we look forward with confidence to the further development of the Oculis Ophthalmology Franchise to address significant unmet medical needs in key areas of ophthalmology."About OculisOculis is a global biopharmaceutical company purposefully driven to save sight, improve eye care and address significant unmet medical needs with breakthrough innovations. Oculis's highly differentiated pipeline includescandidates for topical retinal treatments, topical biologics and disease modifying treatments. With a presence in key international markets, Oculis is poised to deliver life-changing treatments to patients worldwide. Headquartered in Lausanne, Switzerland and with operations in Europe, the U.S. and China, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors.For more information, please visit: www.oculis.com Notes:(1) Baudoin C. Dry Eye Disease, the complex interactions of vicious cycles. EuDESEuropean Dry Eye Society https://www.dryeye-society.com/resources/dry-eye-disease-complex-interactions-vicious-cycles(2) Eric B Papas "The global prevalence of dry eye disease: A Bayesian view" 2021(3) https://dryeyedirectory.com/dry-eye-statistics/(4) DRG Dry Eye Disease Landscape and Forecast 2020(5) Mukamal, R. Why is Dry Eye So Difficult to Treat? 2021 https://www.aao.org/eye-health/tips-prevention/fix-dry-eye-treatment-eyedrops Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)