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Reviva宣布Brilaroxazine治疗精神分裂症的全球关键3期RECOVER试验的阳性结果

Reviva Announces Positive Topline Results from Global Pivotal Phase 3 RECOVER Trial of Brilaroxazine in Schizophrenia

GlobeNewswire 等信源发布 2023-10-30 19:30

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- Successfully met primary endpoint; brilaroxazine 50 mg delivered a statistically significant and clinically meaningful 10.1-point reduction in Positive and Negative Syndrome Scale (PANSS) total score vs. placebo at week 4, p<0.001 - - Statistically significant and clinically meaningful reductions in all major symptom domains and secondary endpoints at week 4 with 50 mg of brilaroxazine vs.

-成功达到主要终点;brilaroxazine 50 mg在第4周与安慰剂相比,阳性和阴性症状量表(PANSS)总分降低10.1分,具有统计学意义和临床意义,p<0.001-所有主要症状域和次要终点的统计学显着性和临床意义降低在第4周与50毫克brilaroxazine vs。

placebo - - Generally well-tolerated with a side effect profile comparable to placebo for the 15 and 50 mg doses of brilaroxazine; discontinuation rates for brilaroxazine lower than placebo - - Topline data from 1-year open-label extension (OLE) trial expected Q4 2024 - - Conference call and webcast today at 8:30 a.m.

安慰剂-一般耐受性良好,副作用与安慰剂相当,15和50毫克剂量的brilaroxazine;brilaroxazine的停药率低于安慰剂-来自1年开放标签延期(OLE)试验的一线数据预计Q4 2024--今天上午8:30召开电话会议和网络广播。

ET - CUPERTINO, Calif., Oct. 30, 2023 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced positive topline results and successful completion of its pivotal Phase 3 RECOVER trial evaluating the efficacy, safety and tolerability of once-daily brilaroxazine, a serotonin-dopamine signaling modulator in adults with schizophrenia.

ET-CUPERTINO,CA,2023年10月30日(GLOBE NEWSWIRE)-Reviva Pharmaceuticals Holdings,Inc。(纳斯达克股票代码:RVPH)(“Reviva”或“Company”),一家后期制药公司,开发治疗方法,寻求解决中枢神经系统(CNS),炎症和心脏代谢疾病领域未满足的医疗需求,今天宣布了积极的一线结果,并成功完成了关键的3期RECOVER试验,评估每日一次brilaroxazine(一种5-羟色胺-多巴胺信号调节剂)在精神分裂症成人中的疗效,安全性和耐受性。

The trial successfully met its primary endpoint, with brilaroxazine at the 50 mg dose achieving a statistically significant and clinically meaningful 10.1-point reduction in Positive and Negative Syndrome Scale (PANSS) total score compared to placebo (-23.9 brilaroxazine 50 mg vs. -13.8 placebo, p<0.001) at week 4.

该试验成功地达到了其主要终点,与安慰剂相比,50mg剂量的brilaroxazine在阳性和阴性症状量表(PANSS)总分上达到统计学显着和临床意义上的10.1分降低(-23.9 brilaroxazine 50mg vs.-13.8安慰剂,p<0.001)在第4周。

Brilaroxazine also achieved statistically significant and clinically meaningful reductions in all major symptom domains and secondary endpoints at week 4 with the 50 mg dose vs. placebo..

Brilaroxazine在第4周时与安慰剂相比,在所有主要症状领域和次要终点方面也取得了统计学显着和临床意义上的减少。。