JIXING Announces First Patients Enrolled in Phase 3 Clinical Study of OC-01 Nasal Spray in China
OC-01 nasal spray is designed to activate the trigeminal parasympathetic pathway resulting in increased production of basal tear film as a treatment for dry eye disease
SHANGHAI, China, July 22, 2022 – 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 patients have been enrolled in its Phase 3 clinical study of OC-01 (varenicline solution) nasal spray in China. The first patients were enrolled in Beijing Tongren Hospital Affiliated to Capital Medical University and Weifang Eye Hospital on the same day. The study is currently carried out in 20 leading clinical centers across China and is designed to evaluate the efficacy and safety of OC-01 nasal spray for the treatment of signs and symptoms of dry eye disease to support a new drug application in China.
OC-01 nasal spray (approved in the U.S. with the brand name of TYRVAYA® ), developed by Oyster Point Pharma, Inc. (Oyster Point Pharma), is a highly selective cholinergic agonist indicated for the treatment of the signs and symptoms of dry eye disease as a multidose preservative-free nasal spray. OC-01 nasal spray is designed to activate the trigeminal parasympathetic pathway resulting in increased production of basal tear film as a treatment for dry eye disease. In August 2021, JIXING entered into an exclusive license and collaboration agreement with Oyster Point Pharma to develop and commercialize OC-01 nasal spray for patients in Greater China. In October 2021, the U.S. Food and Drug Administration (FDA) approved OC-01 nasal spray for the treatment of the signs and symptoms of dry eye disease. It is the first and only nasal spray approved by the FDA for the treatment of the signs and symptoms of dry eye disease.
“There are a large number of dry eye disease patients and prevalence continues to increase year over year. Current therapies only target distinct components of the dry eye cycle and it is difficult to effectively treat dry eye disease at the root.” said Professor Ying Jie, Principal Investigator of the OC-01 nasal spray Phase 3 study in China, Director of Corneal Disease Center and Deputy Director of Ophthalmology Institute at Beijing Tongren Hospital Affiliated to Capital Medical University. “Stimulating natural tear film through nasal spray formulation, OC-01 may be a paradigm-changing way to treat dry eye disease. We hope this medicine will bring better treatment options for Chinese dry eye disease patients in the future.”
“We are very honored to cooperate with 20 leading clinical centers to carry out the Phase 3 clinical study of OC-01 nasal spray in China. This collaboration will continue to drive innovation in dry eye disease treatment. This is also the world's second large-scale Phase 3 clinical study of nasal activation of trigeminal parasympathetic pathway for dry eye disease treatment. The earlier studies, in more than 1,000 patients, were successfully completed in the United States as the evidence to support the product approval by the FDA.” said Larry Li, MD, PhD, Chief Medical Officer of Ophthalmology at JIXING. “Ophthalmology is one of the most important business areas for JIXING. We have established a solid ophthalmic pipeline covering pre-clinical to late-clinical stage drug candidates and are committed to working closely with the medical community to have innovative therapies benefit eye disease patients in China and around the world as soon as possible.”
The OC-01 nasal spray Phase 3 clinical study in China is a multicenter, randomized, controlled, double-masked study designed to evaluate the efficacy and safety of OC-01 nasal spray in adult participants with dry eye disease. The subjects, at least 18 years of age with a physicians’ diagnosis of dry eye disease and meeting all other study eligibility criteria, will be randomized to receive an application of OC-01 or placebo (vehicle) nasal spray. The primary endpoint is the percentage of subjects who achieve ≥10mm improvement in Schirmer’s Test Score from baseline. Other efficacy measures include assessment of Eye Dryness Score and Corneal Fluorescein Staining.
Additional information
Dry eye disease is a chronic condition that is estimated to impact more than 200 million patients in China and is growing in prevalence, significantly influencing a person’s day-to-day quality of life. It can cause persistent stinging, scratching, burning sensations, sensitivity to light, blurred vision, and eye fatigue. Dry eye disease is a multifactorial disease of the ocular surface characterized by disruption of the tear film. Human tear film is a complex mixture of more than 1,500 different proteins, including growth factors and antibodies, as well as numerous classes of lipids and mucins. Natural tear film protects and lubricates the eyes, washes away foreign particles, contains growth factors and antimicrobial components, and creates a smooth surface that forms the primary refractive surface of the eye.
Despite the large prevalence and a significant disease burden, there remains a large unmet need in dry eye disease as current therapies only target distinct components of the dry eye cycle such as inflammation, instead of re-establishing a healthy tear film.
OC-01 (varenicline tartrate) nasal spray is a highly selective cholinergic agonist that is U.S. FDA-approved to treat the signs and symptoms of dry eye disease as a multidose nasal spray. The parasympathetic nervous system, the "rest and digest" system of the body, controls tear film homeostasis partially via the trigeminal nerve, which is accessible within the nose. The efficacy of OC-01 in dry eye disease is believed to be the result of varenicline's activity at heteromeric sub-type(s) of the nicotinic acetylcholine (nACh) receptor where its binding produces agonist activity and activates the trigeminal parasympathetic pathway resulting in increased production of basal tear film as a treatment for dry eye disease. Varenicline binds with high affinity and selectivity at human α4β2, α4α6β2, α3β4, α3α5β4 and α7 neuronal nicotinic acetylcholine receptors. The exact mechanism of action is unknown at this time.
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 Greater China.
Oyster Point Pharma is a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases. In October 2021, Oyster Point Pharma received FDA approval for TYRVAYA® (varenicline solution) Nasal Spray. Oyster Point has a growing pipeline of clinical and pre-clinical programs and continues to expand its research and development pipeline through internal innovation and external collaborations. Oyster Point is continuously striving to advance breakthrough science and deliver therapies seeking to address the unmet needs of patients with ophthalmic disease and the eye care professionals who take care of them. For more information, visit www.oysterpointrx.com and follow @OysterPointRx on Twitter and LinkedIn.
Contacts:
References:
References:
- Wirta, D., Vollmer, P., Paauw, J., et al.& ONSET-2 Study Group. Efficacy and Safety of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease: the ONSET-2 Phase 3, Randomized Trial. Ophthalmology 2021; -:1-9. https: //doi.org/10.1016/j.ophtha.2021.11.004.
- Wirta, D., Torkildsen, G. L., Boehmer, B., Hollander, D. A., Bendert, E., Zeng, L., ... & Nau, J. (2022). ONSET-1 phase 2b randomized trial to evaluate the safety and efficacy of OC-01 (varenicline solution) nasal spray on signs and symptoms of dry eye disease. Cornea.
- Market-Scope. 2020 Dry Eye Products Report: A Global Market Analysis for 2019 to 2025. October 2020.
- Uchino M., Schaumberg D.A. Dry Eye Disease: Impact on Quality of Life and Vision. Curr. Ophthalmol. Rep. 2013; 1:51–57. doi: 10.1007/s40135-013-0009-1.
- Tsubota K, Pflugfelder S, Liu Z, et al. Defining dry eye from a clinical perspective. Int J Mol Sci 2020; 21 (23):9271.doi: 10.3390/ijms21239271.
- Song P, Xia W, Wang M, et al. Variations of dry eye disease prevalence by age, sex, and geographic characteristics in China: a systematic review and meta-analysis. Journal of global health (2018); 8(2):020503. doi: 10.7189/jogh.08.020503.
