NANJING, China, Oct. 30, 2024 /PRNewswire/ -- Oct 24th 2024, Simcere Pharmaceuticals Group Ltd. (2096.HK) announced that a new clinical study with major clinical findings regarding Sanbexin (edaravone and dexborneol concentrated solution for injection) has been published at the 16thWorld Stroke Conference (WSC). According to the latest data, the administration of edaravone dexborneol (Sanbexin®) in patients with acute ischemic stroke (AIS) before receiving endovascular thrombectomy significantly improved neuro-function recovery and reduced disability from stroke.
Presented as a WCS late-breaking oral presentation by Professor Yongjun Wang from Beijing Tiantan Hospital, the study entitled "Treatment of Acute ischemic Stroke with Edaravone dexborneal 2" ("TASTE-2") has caught wide spread attention among neurology academic circle in the world.
Stroke is the leading cause of death and disability in adults in China, while AIS accounts for about 70% of all strokes. About 40% of AIS patients fall into the category of large vessel occlusion (LVO), a subtype of AIS with higher disability and mortality.
After stroke, reperfusion treatments (e.g., thrombolysis and thrombectomy) are used to restores blood supply to the brain as soon as possible. The endovascular thrombectomy (EVT), an important advance in reperfusion therapy in recent years, can achieve recanalization in about 70% to 90% of patients with the LVO stroke, but only half of these patients achieve favorable brain function recovery A significant proportion of the patients who received EVT remain disabled to varying degrees after 90 days of treatment.
TASTE-2 study is a multicenter, double-blind, randomized, placebo-controlled clinical study. From March 2022 to May 2023, a total of 1362 AIS patients with a large-vessel occlusion (LVO) in the anterior circulation were enrolled. Patients were randomly allocated (1:1) to receive edaravone dexborneol (edaravone, 30 mg; (+)-dexborneol, 7.5 mg) or placebo prior to EVT and continued twice a day over a consecutive period of 10-14 days. As a primary efficacy outcome, 379 (55.0%) patients in the edaravone dexborneol group and 333 (49.6%) in the placebo group achieved a mRS 0-2 at day-90 (odds ratio [OR] 1.24, 95% CI 1.00-1.54; risk ratio [RR] 1.11, 95% CI 1.00-1.23). All safety outcomes were similar between both groups. This suggests that Edaravone dexborneol could improve the favorable functional outcome at 90 days in AIS patients within 24-hour of symptom onset who underwent EVT.
Sanbexin® (Edaravone dexborneol Concentrated Solution for Injection) is a multi-targeted brain cell protection agent developed by Simcere Pharmaceutical Co., Ltd, and is the only approved innovative drug in the field of stroke treatment worldwide since 2015. Composed of edaravone and dexborneol, two active ingredients with synergistic anti-oxidant and anti-inflammatory effects, the drug can significantly reduce brain cell injury or impairment caused by AIS.
According to the recommendations of the Stroke Academic Roundtable Meeting (STAIR), brain cytoprotectants can reduce ischemic brain injury, especially when combined with thrombectomy. The scientific community has also been working on brain cytoprotective agents for stroke treatment for decades. However, due to the complexity of stroke pathophysiology, single-target drugs have been found to have limited efficacy and difficult to be developed clinically.
On the other hand, the clinical study of multi-target brain cytoprotectants continue to progress. Previously, the TASTE study led by Professor Yongjun Wang's team in Beijing Tiantan Hospital and the TASTE-SL study led by Professor Dongsheng Fan in Peking University Third Hospital confirmed the efficacy of edaravone dexborneol injection and sublingual tablets in AIS patients who do not receive reperfusion treatment. The latest results of the TASTE-2 study provide key clinical medical evidence for Sanbexn® as a multi-target brain cell protection strategy combined with reperfusion in the treatment of acute ischemic stroke. Sanbexin® is expected to be used as a concomitant drug for endovascular treatment such as thrombectomy, particularly before reperfusion, to further improve the effect of stroke treatment and reduce stroke disability.
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SOURCE Simcere Pharmaceutical Group Limited
