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China NMPA approves CTA of LNZ100 and LNZ101

LENZ Therapeutics is pleased to share that JIXING Pharmaceuticals, our partner for Greater China, has received approval of the Clinical Trial Application (CTA) for the Phase 3 clinical trial of LNZ100 and LNZ101 for the treatment of presbyopia in China.

JIXING Announces the Approval of the Clinical Trial Application for the Phase 3 Clinical Trial of LNZ100 and LNZ101 for the treatment of Presbyopia in China

LNZ100 and LNZ101 aim to be best-in-class treatment options with long-lasting efficacy, good safety profile and high convenience for presbyopia patients in China

SHANGHAI, China, August 3, 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 Center for Drug Evaluation (CDE) of the National Medical Products Administration of the PRC (NMPA) has approved the Clinical Trial Application (CTA) for the Phase 3 clinical trial of LNZ100 (aceclidine)  eye drops and LNZ101 (aceclidine/brimonidine) eye drops for the treatment of Presbyopia in China.

LNZ100 and LNZ101 are being developed by LENZ Therapeutics and JIXING  acquired the Greater China rights for the development and commercialization of the products in April 2022.Aceclidine is a small molecule acetylcholine receptor agonist that causes pupil contraction, or miosis, creating a pinhole effect that improves age-related near vision,also called presbyopia. Aceclidine is the first and only pupil-reducing drug under development that selectively activates the muscarinic acetylcholinergic receptors (mAchR) on the pupillary sphincter. LNZ100 and LNZ101 have best in class potential given the unique pupil selective MOA and safety profile allowing to potentially target a broad patient population.

“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. Current treatments for presbyopia include spectacles or surgery and there is huge unmet medical need for non-invasive, reversible pharmacological treatments,” said Professor Jia Qu, Principal Investigator of the LNZ100/101 Phase 3 study in China, Vice Chairman of Ophthalmology Branch,Chinese Medical Association, Director of optometry department, Wenzhou Medical University. “There are no approved drugs for the treatment of presbyopia in China yet. LNZ100 and LNZ101 have a unique pupil selective MOA and we expect the new products to bring a new treatment option with long-lasting efficacy, good safety profile and convenience for over 400 million presbyopia patients in the future. “

“The Phase 2 studies have shown the potential for LNZ100 and LNZ101 to be best-in-class. The clinical trial approved today is expected to be the largest study and with the highest innovation potential Phase 3 program in the field of presbyopia in China.“said Larry Li, MD, PhD, Chief Medical Officer of Ophthalmology at JIXING. “We are committed to addressing broad eye care needs through revolutionary science. Just earlier this year, varenicline nasal spray received China NDA acceptance as the world’s first drug to treat Dry Eye Disease stimulating natural tear production through a nasal spray formulation, which is another demonstration of our strong commitment to Chinese patients with eye diseases. “

The approved study is a Phase 3, multicenter, randomized, controlled, double-masked 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 the placebo group.