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.”
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, 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.
LNZ100 (aceclidine) eye drops and LNZ101 (aceclidine/brimonidine) eye drops 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 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 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 2 assets in late-stage clinical development (aficamten, etripamil) 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 biopharmaceutical company focused on developing and commercializing innovative therapies to improve vision. Its lead programs, LNZ100 and LNZ101, are aceclidine-based eye drops designed to treat the loss of near vision associated with presbyopia. Presbyopia is estimated to impact approximately 1.8 billion people globally and 128 million people in the United States. LENZ is headquartered in Del Mar, California. For more information, visit: LENZ-Tx.com.
- Mordi J.A., Ciuffreda K.J. Dynamic aspects of accommodation: age and presbyopia. Vision Research (2004);44(6) 591–601.
- Han X, Lee PY, Keel S, et al. Prevalence and incidence of presbyopia in urban Southern China. Br J Ophthalmol (2018);102(11):1538-1542.
- Lu Q, He W, Murthy G.V.S., et al. Presbyopia and Near-Vision Impairment in Rural Northern China.Invest Ophthalmol Vis Sci (2011);52:2300 –2305.
- He M, Abdou A, Naidoo K.S., et al. Prevalence and Correction of Near Vision Impairment at Seven Sites in China, India, Nepal, Niger, South Africa, and the United States. Am J Ophthalmol (2012);154: 107–116.
- Refractive Surgery Group of the Society of Ophthalmologists, Chinese Physicians Association, Expert consensus on laser corneal refractive surgery for Chinese patients with age-related under-adjusted refractive error,（2021）[J]. Chinese Journal of Ophthalmology ,2021,57(9): 651-657.DOI:10.3760/cma.j.cn112142-20210523-00246.
- 2023 China Presbyopia Population Insight Report, The 23rd National Symposium on Cataract and Refractive Surgery of the Chinese Medical Association
- Schallhorn JM, Pantanelli SM, Lin CC, Al-Mohtaseb ZN, Steigleman WA 3rd, Santhiago MR, Olsen TW, Kim SJ, Waite AM, Rose-Nussbaumer JR. Multifocal and Accommodating Intraocular Lenses for the Treatment of Presbyopia: A Report by the American Academy of Ophthalmology. Ophthalmology. 2021Oct;128(10):1469-1482.
- Wolffsohn JS, Davies LN. Presbyopia: Effectiveness of correction strategies.Prog Retin Eye Res. 2019 Jan;68:124-143. doi: 10.1016/j.preteyeres.2018.09.004.Epub 2018 Sep 19.