JIXING Announces the First Patient Enrolled in Phase 3 Clinical Study of LNZ100 and LNZ101 for the Treatment of Presbyopia in China

LNZ100 and LNZ101 aim to be best-in-class treatment options with potential for all-day near vision improvement, favorable tolerability profile and high convenience for presbyopia patients in China

SHANGHAI, China, September 27, 2023 – 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 first patient has been enrolled in its Phase 3 clinical study of LNZ100 (aceclidine) eye drops and LNZ101 (aceclidine/brimonidine) eye drops in China. The first patient was enrolled in the Optometry Hospital of Wenzhou Medical University. Professor Jia Qu, Vice Chairman of Ophthalmology Branch, Chinese Medical Association, Director of optometry department, Wenzhou Medical University and Professor Fan Lv, Head of optometry working-group under Ophthalmology Branch, Chinese Medical Association, Director of National Clinical Medical Research Centre for Eye Diseases is taking the Principal Investigator and Co-Principal Investigator of  LNZ100/101 Phase 3 study in China. The study is currently being carried out in around 20 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 and LNZ101 in participants with presbyopia. The objectives are to assess the potential of LNZ100 and LNZ101 to improve near vision among Chinese presbyopia patients and to evaluate the efficacy and safety profiles.  The trial is expected to enroll 300 subjects, randomized on a 1:1:1 basis to receive LNZ100, LNZ101 or placebo.

“Presbyopia is a physiological phenomenon that is inevitable with age. Studies have shown its prevalence to be close to 100 percent at the age of 52 in China. It is estimated that more than 400 million people in China suffer from presbyopia.” said Professor Jia Qu, Principal Investigator of the study. “Current treatments for presbyopia include spectacles or surgery and there is high unmet clinical need for non-invasive, reversible pharmacological treatments. There are no approved drugs for the treatment of presbyopia in China yet and developing safe and effective drugs for presbyopia have a promising future. ”

“LNZ100 and LNZ101 have a unique pupil selective Mechanism of Action.  The main component aceclidine strongly and selectively activates the muscarinic acetylcholinergic receptors (mAChR) on the pupillary sphincter with potentially superior efficacy and safety profiles comparing to traditional pupil shrinkers.” said Professor Fan Lv, the Co-Principal Investigator of the study. “Through scientifically rigorous protocol design and high-quality project execution, we expect the study will provide evidence on the efficacy and safety of LNZ100 and LNZ101 in improving near vision among Chinese presbyopia patients. We expect innovative product candidates that have long-lasting efficacy, good safety profile and convenience for presbyopia patients could expand the treatment options for presbyopia in the future.”  

“The Phase 2 studies have shown the potential for LNZ100 and LNZ101 to be best-in-class. We are very honored to cooperate with leading clinical centers to carry out the Phase 3 clinical study targeting the presbyopia population in China. The results of this study could provide evidence for broad patient benefits.“ said Larry Li, MD, PhD, Chief Medical Officer of Ophthalmology at JIXING. “Ophthalmology is one of the most important therapeutic areas for JIXING. We have established a solid ophthalmic pipeline covering pre-clinical to late-clinical stage investigational drugs and are committed to working closely with the leading investigators to help support the “Healthy China” agenda.”