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变构离子通道调节剂开发商Bionomics公布BNC210治疗创伤后应激障碍患者的ATTUNE 2b期试验全数据集分析结果

Bionomics Reports Results of the Full Dataset Analysis from ATTUNE Phase 2b Trial of BNC210 in Patients with Post-Traumatic Stress Disorder

GlobeNewswire 等信源发布 2024-03-21 18:00

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BNC210 demonstrated a statistically significant improvement in post-traumatic stress disorder (PTSD) symptom severity with a clinically meaningful effect size suggesting a potential advantage over approved medications. BNC210’s emerging safety and tolerability profile continues to support its differentiation over approved, available, and experimental psychoactive treatments.

BNC210表现出创伤后应激障碍(PTSD)症状严重程度的统计学显着改善,具有临床意义的效应大小,表明其优于批准的药物。BNC210新兴的安全性和耐受性概况继续支持其在批准,可用和实验性精神活性治疗方面的差异。

Bionomics will meet with the U.S. Food & Drug Administration (FDA) to discuss BNC210’s registrational program in PTSD by end of the second quarter of 2024; Late-stage trial initiation is expected by the end of 2024. ADELAIDE, Australia and CAMBRIDGE, Mass., March 21, 2024 (GLOBE NEWSWIRE) -- Bionomics Limited (Nasdaq: BNOX) (Bionomics or Company), a clinical-stage biotechnology company developing novel, first-in-class, allosteric ion channel modulators to treat patients suffering from serious central nervous system (CNS) disorders with high unmet medical need, today announced the release of the full dataset analysis from its Phase 2b ATTUNE trial in patients with post-traumatic stress disorder.

Bionomics将于2024年第二季度末与美国食品和药物管理局(FDA)会面,讨论BNC210在创伤后应激障碍中的注册计划;预计2024年底将开始后期试验。澳大利亚阿德莱德和马萨诸塞州剑桥,2024年3月21日(环球通讯社)--Bionomics Limited(纳斯达克:BNOX)(Bionomics或Company),一家临床阶段的生物技术公司,开发新型一流的变构离子通道调节剂,以治疗患有严重中枢神经系统(CNS)疾病且医疗需求未得到满足的患者,今天宣布发布其针对创伤后应激障碍患者的2b期ATTUNE试验的完整数据集分析。

In September 2023, Bionomics reported the topline results for the Phase 2b ATTUNE trial of BNC210 in patients with PTSD demonstrating that the trial met its primary endpoint and several secondary endpoints, and that BNC210 was generally well tolerated. The full data analysis is detailed below and in an accompanying presentation of the results that is posted on the Company’s website.

2023年9月,Bionomics报道了创伤后应激障碍患者BNC210 2b期ATTUNE试验的主要结果,表明该试验符合其主要终点和几个次要终点,并且BNC210通常耐受性良好。下面详细介绍了完整的数据分析,并在公司网站上发布了结果的附带说明。

“The full results of the ATTUNE Phase 2b trial further strengthen, the already compelling, topline results and position BNC210 as a potential highly differentiated treatment with rapid onset and durable efficacy that could improve outcomes for patients with PTSD. There are over 13 million Americans adults suffering from PTSD, ye.

“ATTUNE 2b期试验的全部结果进一步巩固了已经令人信服的主要结果,并将BNC210定位为一种潜在的高度分化治疗方法,具有快速起效和持久疗效,可以改善创伤后应激障碍患者的预后。ye,美国有1300多万成年人患有创伤后应激障碍。