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.
Presbyopia is a physiological phenomenon in which near objects appear blurred with increasing age. It is caused by the gradual hardening of the lens and decrease in the function of the ciliary muscles. This results in a decline of the eye's adjustment function, and the inability to focus the image of near objects on the retina, leading to a decline in near vision. Studies have shown that the onset of presbyopia occurs around the age of 38, with a prevalence rate of nearly 100 percent at the age of 52. It is estimated that more than 400 million people in China suffer from presbyopia.
Currently, the treatment options for presbyopia are very limited, relying mainly on spectacles or surgery. 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 until now.
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 ideally 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 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.
JIXING’s cardiovascular portfolio includes 3 assets in late-stage clinical development (aficamten, etripamil, omecamtiv mecarbil) and 1 in pre-clinical stage (JX09). 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.
LENZ Therapeutics is a late-stage clinical company developing innovative ophthalmic pharmaceutical products that improve vision. Its lead programs, LNZ100 and LNZ101, are aceclidine-based eye drops designed to correct the loss of near vision associated with presbyopia. Presbyopia is estimated to impact almost two billion people globally and more than 120 million people in the United States. LENZ is headquartered in San Diego, California, and is backed by venture capital investors, including RA Capital, Alpha Wave Ventures, Versant Ventures, Point 72 Asset Management, Sectoral Asset Management, RTW Investments, and others. For more information, visit: LENZ-Tx.com.
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