JIXING Announces the Successful Completion of Patient Enrollment in Phase 3 Clinical Study of LNZ100 for the Treatment of Presbyopia in China
LNZ100 could potentially be the best-in-class non-invasive treatment for presbyopia
The Phase 3 design is a 4-week efficacy study followed by a 5-month extension safety study
SHANGHAI, China, August 19, 2024 – Ji Xing Pharmaceuticals Limited (JIXING), a clinical-stage biopharmaceutical company committed to bringing innovative medicines to underserved Chinese patients with serious and life-threatening diseases, announces
that the investigational ophthalmic products, LNZ100 (aceclidine) eye drops, have completed patient enrollment in a Phase 3 clinical study in China for the treatment of presbyopia.
Professor Jia Qu, Vice Chairman of Ophthalmology Branch, Chinese Medical Association, Director of optometry department, Wenzhou Medical University and Professor Fan Lyu, Head of optometry working-group under Ophthalmology Branch, Chinese Medical Association, Director of National Clinical Medical Research Centre for Eye Diseases are the Principal Investigator and Co-Principal Investigator of the LNZ100 Phase 3 study in China. The study is currently being carried out in 19 leading clinical centers across China to support a new drug application in China.
The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study, designed to evaluate the efficacy and safety of LNZ100 (an aceclidine-based ophthalmic solution) in participants with presbyopia. The objectives are to assess the potential of LNZ100 to improve near vision among Chinese presbyopia patients and to evaluate the efficacy and safety profiles. The trial has fully enrolled with 300 participants.
"We are delighted to have participated in and successfully completed the patient enrollment for this study. Throughout the process, we obtained a thorough grasp of the enthusiasm and need for novel presbyopia treatments from both the physician and patient perspectives. This experience reinforces the importance of and urgency for the development of novel, effective presbyopia treatments to address this unmet medical need," said Professor Jia Qu, Principal Investigator of the study. “Current treatments for presbyopia include spectacles. However, there are significant unmet requirements for non-invasive and reversible therapies in the field of presbyopia treatment. We are hopeful that the result of this trail will lead to a sustained breakthrough in this field in China, providing an excellent, safe, and convenient treatment options for patients with presbyopia.
Last week, LENZ Therapeutics, the U.S. based originator, has submitted a New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for LNZ100 for the treatment of presbyopia. The NDA submission is supported by positive data from the pivotal Phase 3 CLARITY study of LNZ100 for the treatment of presbyopia. In the Phase 3 CLARITY study, LNZ100 achieved all primary and secondary near vision improvement endpoints with statistically significant three-lines or greater improvement in Best Corrected Distance Visual Acuity (BCDVA) at near, without losing one line or more in distance visual acuity, demonstrating LNZ100 was well tolerated with no serious treatment-related adverse events observed in the over 30,000 treatment days monitored in the CLARITY study.
"The main active ingredient of LNZ100, aceclidine, is a small molecule acetylcholine receptor (mAChR) agonist that causes temporary pupil constriction, resulting in an optical effect that significantly extends the depth of focus and improves the quality of vision." said Professor Fan Lyu, the Co-Principal Investigator of the study. "Previous studies in the U.S. have shown that this unique formulation has an ideal mechanism of action, based on its outstanding selective, long-lasting pupillary action, which produces a desirable pupil constriction effect and avoids stimulation of the ciliary muscles and myopic shift, and therefore has the potential to be used in the widest range of population. We hope that the results of this clinical study will provide strong efficacy and safety evidence to help improve near-vision in the Chinese presbyopia population and close gaps in the current presbyopia treatment field."
"We are very excited to join hands with the top clinical research centers and research service providers in China to advance the implementation of the Phase 3 clinical trial of the innovative drug for the treatment of patients with presbyopia in China. The results of the U.S. Phase 3 study released this year have confirmed that LNZ100 has a great potential to become the best-in-class presbyopia treatment." Dr. Zhiping Li, Chief Medical Officer, Ophthalmology of JIXING, said, "We look forward to the results of this study providing solid scientific evidence to show the benefit for a wide presbyopia population."
Additional information
Presbyopia is a physiological phenomenon associated with aging that results in a progressively worsening ability to see nearby objects clearly. It is caused by the gradual hardening of the lens. This results in a decline of the eye's adjustment function, and the inability to focus the image of nearby objects on the retina, leading to a decline in near vision. Studies have shown that the onset of presbyopia typically occurs around the age of 38, reaching a prevalence rate of nearly 100 percent at the age of 52 in China. It is estimated that more than 400 million people in China suffer from presbyopia.
Currently, the treatment options for presbyopia are very limited. Wearing glasses requires frequent removal and insertion, causing many inconveniences in work and life. Surgery, as an irreversible invasive operation, has a very limited acceptance. There are no approved drugs for the treatment of presbyopia in China and the medical need for non-invasive, safe, efficient and reversible treatments for presbyopia remains unsolved.
LNZ100 (aceclidine) eye drops are being developed by LENZ Therapeutics and JIXING acquired the Greater China rights for the development and commercialization in April 2022. Aceclidine is a small molecule acetylcholine receptor agonist that causes pupil contraction, or miosis, creating a pinhole effect that improves near vision. Studies have shown that aceclidine's mechanism of action (MOA) is well positioned to create a pinhole pupil effect while avoiding the impairment of distance vision called myopic shift. Aceclidine's unique pupil selective MOA, in which miosis is decoupled from myopic shift, is expected to allow it to target a broad patient population.
JIXING is a biopharmaceutical company headquartered in Shanghai committed to bringing innovative science and medicines to underserved patients in China and around the world with serious and life-threatening diseases. Backed by RTW Investments, LP, JIXING was founded in 2019 and partners with global biotechnology companies to develop and commercialize novel, innovative therapeutics to treat unmet medical needs in cardiovascular and ophthalmic diseases. With a strong and further developing asset pipeline, seasoned management team, and patient-centric focus, JIXING is dedicated to delivering a meaningful and lasting impact on patients in China and around the world.
JIXING's cardiovascular portfolio includes 2 assets in late-stage clinical development (Aficamten, Etripamil), and 2 assets in preclinical development, JX09 for hypertension and JX10 for acute ischemic stroke. JIXING's ophthalmology portfolio includes 4 assets in late-stage clinical development (varenicline solution nasal spray/US brand name TYRVAYA®, OC-02 nasal spray, JX06/LNZ100, JX07/LNZ101) and 1 asset in pre-clinical stage (JX08). For further information about JIXING, please visit www.jixing.com.
