On May 5, 2022, Simcere Pharmaceuticals (2096.HK) announced that，a phase 3 registrational clinical trial of Sanbexin Sublingual Tablet for the treatment of acute ischemic stroke (AIS) in China has completed the enrollment of all subjects ahead of schedule and is entering the follow-up and data analysis period.
This randomized multi-centered, double-blinded, paralleled, and placebo-controlled phase 3 trial was headed by Peking University Third Hospital and involved nearly 40 research sites across the country. A total of 914 patients aged 18-80 hospitalized with AIS within 48 hours of onset were enrolled. The primary endpoint of the study is the proportion of subjects with mRS (modified Rankin Scale, for measuring the degree of disability after stroke) score ≤1 on day 90 after treatment. Meanwhile, the study will also evaluate other efficacy and safety parameter as well as exploring biomarkers of stroke.
Sanbexin sublingual tablet is a new drug jointly developed by Simcere and NeuroDawn based on the clinical demands of AIS patients for more timely and sufficient treatment after stroke onset. The main ingredients are similar to that of Sanbaxin® (Edaravone and Dexborneol Concentrated Solution for Injection), which is highly permeable by the blood-brain barrier to exert anti-inflammatory and anti-free radical effect in the brain. The sublingual dose form is designed for direct absorption by the sublingual mucosa that bypasses the first-pass metabolism and hence facilitates rapid absorption of the drug into the systemic circulation. More importantly, sublingual tablet has better safety and accessibility than injections, therefore is potentially more suitable for timely rescue of AIS patients before they reach hospital or medication at home after being discharged from hospital.
The phase 3 clinical trial of Sanbexin sublingual tablet started FPI in June 2021, and completed the enrollment of all 914 patients within 10 months. The data derived from this study will likely support the NDA of this new product in China in 2023. A phase 1 clinical trial has also been initiated in the United States, where the product is designated as an orphan drug by the FDA. Additionally, the core patents have been granted in multiple countries in the world.
The sequential treatment of Sanbexin® injection + sublingual tablet is expected to provide AIS patients across the world with a new option that covers the entire course of stroke treatment.