Tag: trial

HONG KONG, Aug 24, 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 and development, manufacturing and commercialization of therapies that address significant unmet medical needs, today announced its interim results for the six months ended 30 June 2022 ("Reporting Period").Zhaoke Ophthalmology is strategically focused on treatments that cover a wide range of ophthalmic diseases, with one of the largest and most comprehensive drug portfolios of innovative and generic treatments covering the six major eye diseases across both the front-and back-of-the-eye, including dry eye disease ("DED"), myopia, presbyopia, wet age-related macular degeneration ("wAMD"), diabetic macular edema ("DME") and glaucoma. The Company's portfolio includes several potential blockbuster innovative drug candidates.Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, said, "Innovation and commercialization are Zhaoke Ophthalmology's dual focuses for 2022. We are proud to say that in the first half of 2022, we accomplished multiple milestone achievements in both areas, despite the challenging environment in China and globally."The first highlight has been the completion of patient recruitment for concurrent Phase III clinical trials for one of the Company's core innovative drug candidates, NVK002, significantly ahead of schedule. In July 2022, NVK002, a treatment for myopia progression in children and adolescents, completed the recruitment for its concurrent two-year Phase III clinical trial ("China CHAMP") and one-year Phase III bridging trial ("Mini-CHAMP"). The China CHAMP trial involves 19 centers and 770 patients, and the Mini-CHAMP involves 18 centers and 526 patients. The former completed enrolment on 21 July 2022, two months ahead of schedule, while the latter completed enrolment on 28 July 2022, three months ahead of schedule. Dr. Li continued, "Completing patient recruitment for these clinical trials so far ahead of schedule reflects both the strong capabilities and expertise of Zhaoke Ophthalmology's clinical operations team, as well as the immense demand for a safe and efficacious treatment for myopia progression in China."The second highlight is the launch of Zhaoke Ophthalmology's first commercialized product, "Baodeshi" the Heat Compress Eyepatch, a category 2 medical device for reducing symptoms of mild cases of dry eye. The Eyepatch launch, will accelerate the Company's efforts to establish an omnichannel commercial strategy Dr. Li added, "We are excited about the recent launch of the "Baodeshi" Heat Compress Eyepatch with an official flagship store on Tmall. The launch of the eyepatch exemplifies our core belief that a combination of drug regimen therapy and medical device will ultimately deliver the best treatment options for many patients. Moreover, the eyepatch also helps to increase the general public's awareness and knowledge of eye diseases and treatment solutions in China."During the Reporting period, Zhaoke Ophthalmology achieved several milestones across its comprehensive drug pipeline. The Company's self-developed innovative drug, CsA Ophthalmic Gel for DED, submitted a New Drug Application (NDA) to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. The submission was accepted in June 2022 and is now under review by the CDE. In May 2022, Zhaoke Ophthalmology announced a new partnership with Visus, a US pharmaceutical company, to license BRIMOCHOL(TM) PF and Carbachol PF, innovative drugs for presbyopia. The introduction of the two innovative assets enabled Zhaoke Ophthalmology to become the first ophthalmic pharmaceutical company in China with innovative drugs in advanced clinical development covering the three major front-of-the-eye diseases - dry eye, myopia, and presbyopia. Also, TAB014, the company's first drug for the treatment of back-of-the-eye diseases, initiated a Phase III clinical trial and the first patient was enrolled for wAMD in June 2022. Zhaoke Ophthalmology continues to focus on enhancing the Company's innovative omni-channel strategy through expanding its partnership network and strengthening digital engagement The strategy was kick-started with the launch of the Zhaoke Boshi WeChat platform in September 2021, in response to the demand from the ophthalmologist community for high quality content focusing on cutting-edge ophthalmology research in China and globally. This platform not only showcases outstanding content, but also allows leading KOLs to share their knowledge and best practices and facilitates discussions in the Chinese ophthalmologist community. Less than a year after its launch, the Zhaoke Boshi platform has attracted close to 10,000 followers. At the same time, over 60 leading KOLs in various fields of ophthalmology have contributed content or participated in livestream discussions on the platform.Following the momentum established by Zhaoke Boshi, the launch of "Baodeshi" Heat compress eyepatch on Tmall with its own flagship store, marks the next milestone in our omni-channel commercialization strategy by establishing a direct channel of interaction with dry eye patients and eye-health-conscious consumers alike. In February 2022, the Company established a corporate gift agreement with John Hopkins University, one of the world's leading private research institutes, to support translational research and academic exchange. In March 2022, Zhaoke Ophthalmology signed strategic partnership agreements with three of China's leading pharmaceutical supply chain service companies, Sinopharm Group Distribution Co., Ltd, Shanghai Pharmaceuticals Co., Ltd., and China Resources Pharmaceutical Commercial Group Limited to collaborate in areas including procurement models, logistics management, market developments, joint projects and information communication.Turning to financial performance, Zhaoke Ophthalmology recorded a total loss of approximately RMB161.0 million for the six months ended 30 June 2022, compared to an approximately RMB1,987.7 million for the same period in 2021. During the period, the Company's R&D expenses reached approximately RMB100.9 million, compared to approximately RMB123.4 million for the six months ended 30 June 2021. Whilst the decrease in R&D expenses is mostly a result of the timing of various clinical programs, the Company is strictly focused on exercising discipline towards capital expenditure in light of overall financial market conditions.As at the end of the Reporting Period, Zhaoke Ophthalmology recorded cash, cash equivalents and time deposits of approximately RMB1,860.3 million.Dr. Li continued, "Looking forward, we anticipate the second half of 2022 will be an exciting period for Zhaoke Ophthalmology. Several milestones are expected to be completed in the coming months, including our partner Vyluma Inc. announcing the clinical results of their global three-year Phase III trial for NVK002. This will be an important step towards making this drug potentially the first US FDA-approved low-dose atropine for the treatment of myopia progression in children and adolescents."He added, "Meanwhile, we will continue to adhere to our strategy ando combine our strong R&D capabilities, comprehensive asset portfolio and innovative commercialization approach to capture the huge unmet medical need not only in China, but also globally. With the dedication and unwavering passion of our employees, we are well positioned to capture the tremendous market opportunity." Zhaoke Ophthalmology highlighted several pipeline updates as a part of the results announcement:CsA Ophthalmic Gel for DED (self-developed)OverviewCsA Ophthalmic Gel is an innovative drug being developed by us for the treatment of moderate to severe DED. It is a single, daily dose hydrogel which eliminates daytime administration and the associated discomfort and inconvenience and aims to dramatically improve patients' treatment compliance and quality of life. It is a proprietary hydrogel with patent approval in China and internationally. This novel formulation enhances the pharmacokinetic profiles of CsA on the ocular surface allowing efficacy similar to that of Cyclosporine A products currently available for DED. However, unlike the current treatment, CsA Ophthalmic Gel's unique formulation stays on the eye for longer, requiring only once-a-day dosing (compared with traditional twice-a-day dosing). In the Phase III clinical trial for CsA Ophthalmic Gel, the treatment also showed a faster onset of action by demonstrating efficacy at around a two-week period, while other CsA drugs normally take around seven to eight weeks.Updates during the Reporting PeriodOn June 8, 2022, the NDA for CsA Ophthalmic Gel was accepted for review by the CDE.Our Company continues to target the commercialization of CsA Ophthalmic Gel in China as early as 2023. Due to the treatment's potential to benefit millions of people globally, we are also exploring opportunities outside of China.NVK002 (Atropine) for Myopia (partnered with Vyluma)OverviewTo date, low concentration atropine is the only medication that is consistently effective in myopia progression control among children and adolescents. Our innovative treatment, NVK002, is currently positioned as the first clinically-proven pharmaceutical product approved for treating the progression of myopia globally. This treatment has a proprietary formulation that successfully addresses the instability of low-concentration atropine and is preservative-free with an expected shelf life of more than 24 months. The clinical development of NVK002 involves two different concentrations of preservative-free atropine (0.01% and 0.02%) to determine the efficacy, safety and tolerability in children and adolescents with myopia, offering a distinct choice for doctors and patients.Our Company's licensing partner for NVK002 is Vyluma, a wholly owned subsidiary of US-based Nevakar. Vyluma is currently conducting the Phase III clinical trial for NVK002 in the US and Europe. The results of the three-year trial are expected to be available by the end of 2022 and will be followed by an NDA submission to the FDA in 2023.In September 2021, we received approval from the CDE to initiate two concurrent Phase III clinical trials, including China CHAMP and Mini-CHAMP. Combined with global data from Vyluma's Phase III clinical trial in the US and Europe, the overall trial for NVK002 will be one of the most comprehensive and robust Phase III clinical trials for low dose atropine use in the world.Updates during the Reporting PeriodThe main objective of China CHAMP and Mini-CHAMP is to evaluate the efficacy and safety of NVK002 in the treatment of myopia progression in children and adolescents from 3 to 17 years old.Led by Professor Wang Ningli from Beijing Tongren Hospital as the principal investigator, the China CHAMP trial involves 19 centers and has completed the enrollment of 777 patients. Co-led by Professor Qu Xiaomei from the Eye and ENT Hospital of Fudan University and Professor Yang Xiao from the Zhongshan Ophthalmic Center of Sun Yat-Sen University as the principal investigators, the Mini-CHAMP trial involves 18 centers and has completed the enrollment of 526 patients.Both the China CHAMP and Mini-CHAMP have completed patient recruitment in July 2022, representing two and three months significantly ahead of schedule respectively. The early completion of patient recruitment across both trials gives our Company a strong head start in moving towards the goal of leading the market in launching a myopia progression treatment.The drug could be available in the PRC market as early as 2024, potentially making Zhaoke Ophthalmology one of the first companies to commercialize a myopia drug in the PRC market.BRIMOCHOL(TM) PF and Carbachol PF (partnered with Visus)OverviewBRIMOCHOL(TM) PF and Carbachol PF are pupil-modulating eye drops designed to be once-daily, preservative-free therapeutics to correct the loss of near vision associated with presbyopia. BRIMOCHOL(TM) PF is a fixed-dose combination of carbachol (a cholinergic agent) and brimonidine tartrate (an alpha-2 agonist). Carbachol PF is a proprietary, preservative-free formulation of carbachol monotherapy. Both investigational therapies reduce the size of the pupil resulting in a "pinhole effect" so that only centrally focused light rays are able to enter the eye, thereby sharpening both near and intermediate images.In the VIVID Phase II study conducted by Visus in the US, both formulations met primary and secondary endpoints, demonstrating a three-line improvement in near visual acuity with no loss of distance vision out to nine hours. Both BRIMOCHOL(TM) PF and Carbachol PF were well tolerated with no serious adverse events. Phase III pivotal trials commenced in March 2022, with interim topline data expected in the fourth quarter of 2022.Corresponding to the ongoing Phase III clinical study of BRIMOCHOL(TM)PF and Carbachol PF in the US, we plan to launch a clinical study in China for presbyopia in the near future.TAB014 (Bevacizumab) for wAMD (partnered with TOT BIOPHARM)OverviewTAB014 is the first clinical-stage bevacizumab-based antibody indicated for wAMD in China. Bevacizumab is a clinically validated anti-VEGF drug. Globally, bevacizumab is approved for oncology treatment through intravenous infusion. However, there has been increasing off label use of bevacizumab via intravitrealinjection for the treatment of wAMD.Updates during the Reporting PeriodIn March 2022, Zhaoke Guangzhou, a wholly-owned subsidiary of our Company, and TOT BIOPHARM Co., Ltd. Suzhou, a wholly owned subsidiary of TOT BIOPHARM, entered into a supplemental agreement - pursuant to which Zhaoke Guangzhou will have full control in the execution of clinical trials and the ultimate decision-making power in the development and commercialization of TAB014 in China, Hong Kong and Macau. Zhaoke Guangzhou has also been given the right to develop TAB014 for other ophthalmic indications besides wAMD or novel formulations for ophthalmic indications.On June 28, 2022, we completed the recruitment of the first patient for the Phase III clinical trial of TAB014.The Phase III clinical trial of TAB014 is a randomized, double-blind and noninferiority study. The main objective of the study is to evaluate the change from baseline in best corrected visual acuity (BCVA) at week 52 in TAB014-treated subjects group compared with Lucentis(R)-treated subjects group. The study will involve up to approximately 60 centers and enroll a total of 488 patients, led by Professor Chen Youxin from Peking Union Medical College Hospital as the principal investigator.ZKY001 (self-developed)OverviewZKY001 is a seven-amino acid peptide derived from the functional fragment of Thymosin beta4 that binds actin, a type of protein that plays a central role in cell structure and movement. We are exploring multiple indications as we believe this asset can potentially be applied to multiple disease indications.ZKY001 has broad applications in the healing of corneal wounds and can potentially be used in multiple indications. We are currently exploring four indications for ZKY001, including CED, corneal epithelial defect, TPRK, a surgical treatment for myopia, pterygium, a growth in the cornea or the conjunctiva, and NK, a rare degenerative corneal disease.Updates during the Reporting PeriodWe completed treatment for the last patient in the Phase II clinical trial of ZKY001 for CED in February 2022. On March 16, 2022, the first patient was enrolled for Phase II clinical trial for pterygium disease. On August 5, 2022, the first patient was enrolled for the Phase II clinical trial for TPRK. We will refine our clinical development strategy for this asset once we have the trial results across multiple indications.NTC010OverviewNTC010 is a fixed dose combination of antibiotics and steroids to prevent infection and inflammation for patients undergoing cataract surgery. The drug belongs to a new generation of antibiotics, which increase efficiency and cover a wider range of bacteria. The drug also shortens the duration of the treatment by half - from 14 to seven days - making it beneficial to patients' overall health and helping to prevent antibiotic overuse. The drug has already been approved in seven European countries. We plan to submit an NDA to the NMPA in the near future.PAN-90806 (VEGFR2 inhibitor) for wAMD and DME (partnered with PanOptica)OverviewPAN-90806 is an innovative drug indicated in the treatment of wAMD, as well as DME, the leading cause of blindness in diabetic patients worldwide. PAN-90806 is a novel eye drop formulation, which decreases the number of injections required. If approved as a maintenance therapy, PAN-90806 will bring significant convenience and a less invasive treatment alternative for patients. This will reduce the frequency of intravitreal injections and other treatment issues associated with mainstream anti-VEGF therapies while at the same time maintaining visual stability. PAN-90806 is expected to significantly reduce treatment discontinuation, and therefore slow underlying disease progression through improved patient comfort, acceptance, convenience and compliance.We are currently focused on optimizing the formulation of PAN-90806. Subject to regulatory approvals, our Company plans to commence human trials after completion of requisite animal studies.Generic DrugsWe follow a balanced approach in designing our drug pipeline. In addition to innovative drug candidates, our Company has several key generic drugs in the pipeline. Generic drugs address a substantial portion of ophthalmic medical needs in China. From a market demand perspective, our generic pipeline complements our innovative pipeline and better positions us to become an efficient one-stop comprehensive solution provider. From a supply perspective, our generic programs also offer several strategic benefits.During the Reporting Period, we continue to focus on commercializing Bimatoprost Timolol, a generic drug for glaucoma, as our first commercialized drug asset. The launch of this treatment will position us in the under-served glaucoma market and prepare us for the future commercial launch of our innovative drugs.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.comBowen Chui, DirectorM: +852 9783 0643E: bowen.chui@artemisassociates.comIris Pei, DirectorM: +86 15000 465 016E: iris.pei@artemisassociates.com Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)