Findings of a Phase III Clinical Study of Sanbexin® Sublingual Tablets Published in JAMA

NANJING, China, Feb. 21, 2024 /PRNewswire/ -- On February 19, 2024, the Journal of American Medical Association•Neurology (JAMA NEUROLOGY, IF: 29.0) published online the key findings of a phase III clinical study (NCT04950920) (the "TASTE-SL Study") investigating Sanbexin® (a combination of edaravone and dexborneol) sublingual tablets for the treatment of acute ischemic stroke (the "AIS").

The findings indicate that Sanbexin® sublingual tablets has substantially enhanced neurological functions and independence in daily living activities among AIS patients following the treatment.

Sanbexin® sublingual tablets is an innovative drug jointly developed by Simcere Pharmaceutical Group Ltd. ("Simcere") and Neurodawn Pharmaceutical Co., Ltd. ("Neurodawn"). The Sanbexin® sublingual tablets is expected to become a sequential therapy with Simcere's marketed Sanbexin® (Edaravone and Dexborneol Concentrated Solution for Injection) and allow patients to receive a complete course of treatment both in and outside of the hospital. On June 28, 2023, the New Drug Application (NDA) of the Sanbexin® sublingual tablets was accepted by the National Medical Products Administration of China (the "NMPA"). The first indication is for the improvement of neurological symptoms, activities of daily living, and functional disabilities caused by AIS.

Sanbexin® sublingual tablet offers a novel approach to stroke treatment, leveraging the power of edaravone and dexborneol. The two active ingredients dissolve quickly under the tongue and are rapidly absorbed into the bloodstream via the sublingual venous plexus, providing unparalleled anti-inflammatory and free radical scavenging capabilities. By minimizing the cascading damage caused by AIS and protecting brain cells, this innovative formulation has the potential to expand treatment options and improve patient compliance. With its innovative sublingual delivery system, Sanbexin® is poised to revolutionize stroke care.

The TASTE-SL study, published in JAMA Neurology, is a Phase III clinical trial that evaluated the safety and efficacy of Sanbexin® sublingual tablets in AIA patients. This multi-center, randomized, double-blind, placebo-controlled study enrolled 914 AIS patients within 48 hours of onset at 33 research sites in China from June 28, 2021, to August 10, 2022. Of these, 450 patients in the Sanbexin® sublingual tablets group received 36mg dose of sublingual edaravone dexborneol (edaravone 30mg, dexborneol 6mg) twice a day for 14 consecutive days), while 464 patients in the placebo group received a sublingual placebo (edaravone 0mg, dexborneol 60μg) twice a day for 14 consecutive days.

The findings from the clinical trial suggest that the Sanbexin® sublingual tablets offer significant benefits for the treatment of AIS. The study, which included 302 patients, showed that those taking Sanbexin® sublingual tablets had a higher proportion of good functional outcomes (mRS score 0-1) on day 90 post-randomization compared to the placebo group: – 64.4% vs. 54.7%. The odds ratio was 1.50 (95% CI 1.15-1.95, p=0.003).

Subgroup analyses of different demographic and clinical characteristics revealed consistent improvements in neurological function for the Sanbexin® sublingual tablet, regardless of age (≤65 or >65), gender, time from stroke onset to treatment (≤24 hours or >24 hours), presence of hypertension, hyperlipemia, diabetes, heart disease, or renal dysfunction.

The Sanbexin® sublingual tablets demonstrated a favorable safety profile, with comparable rates of adverse events (AEs) and treatment-related AEs within 90 days between the two groups. This data strengthens Sanbexin® sublingual tablets' position as an effective and well-tolerated treatment option for AIS patients.

Prof. Wang Yongjun, President of Beijing Tiantan Hospital of Capital Medical University, said, "In the field of stroke treatment, the continued exploration of brain cell protection therapy is beginning to show promise. Following the TASTE study, which validated the clinical benefit of edaravone dexamethasone injection, the TASTE-SL study further confirmed the efficacy and safety of the sublingual dosage form in the AIS population, and a more convenient way of administering the drug is expected to push the brain cell protection to home treatment."

Prof. Fan Dongsheng from the Peking University Third Hospital said, "Sanbexin® sublingual tablets is effective in improving neurological function recovery and independent living ability of ischemic stroke patients after treatment and apply to a variety of treatment scenarios. This Phase III study of Sanbexin® sublingual tablet also provides a high-quality evidence-based basis for clinical brain cell protection, which provides a strong guarantee for stroke treatment."

source: Simcere Pharmaceutical Group Limited