Expects to announce topline data expected in the November/December timeframe.Enrolled patients had underlying medical conditions that are known risk factors for dementia that NE3107 has the potential to improve. CARSON CITY, Nev., Sept. 26, 2023 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that the last patient has completed the last visit at week 30 in its multicenter, randomized, placebo-controlled Phase 3 study (NCT04669028) of NE3107 in patients with mild to moderate Alzheimer’s Disease (AD).

预计将在11月/12月期间公布预期的顶级数据。入选患者的潜在医疗条件是已知的痴呆风险因素，NE3107有可能改善。2023年9月26日（GLOBE NEWSWIRE）-BioVie Inc.（纳斯达克股票代码：BIVI）（“BioVie”或“公司”）临床阶段公司开发创新药物疗法治疗神经和神经退行性疾病和晚期肝病，今天宣布最后一名患者在第30周完成了最后一次就诊，随机分组，NE3107在轻度至中度阿尔茨海默病（AD）患者中的安慰剂对照3期研究（NCT04669028）。

“Now that the last patient has completed the last treatment visit, our clinical team can begin the process leading to database lock,” stated Dr. Joseph Palumbo, BioVie’s Head of R&D and Chief Medical Officer. “We remain on track to announce topline data on the cognitive and functional assessments by approximately the end of November 2023 with additional biomarker data on TNFα, amyloid β, phospho-tau, Neurofilament light (NfL), and others to follow.” “We are cautiously optimistic about what to expect later this year based on data previously seen from our Phase 2 exploratory biomarker trial,” commented Cuong Do, BioVie’s President and CEO.

BioVie研发负责人兼首席医疗官Joseph Palumbo博士说：“既然最后一位患者完成了最后一次治疗访问，我们的临床团队就可以开始导致数据库锁定的过程。”。“大约在2023年11月底，我们仍然在宣布关于认知和功能评估的顶级数据，以及TNFα，淀粉样蛋白β，磷酸化tau，神经丝光（NfL）等其他生物标志物数据。BioVie的总裁兼首席执行官Cuong Do评论说：“根据之前在第二阶段探索性生物标志物试验中看到的数据，我们对今年晚些时候的预期持谨慎乐观的态度。

“We do not need to show a reversal of cognitive decline as demonstrated in the Phase 2 trial for the current trial to be considered successful. If NE3107 demonstrates a slowing of cognitive decline equivalent to or better than the various monoclonal antibodies, we win because NE3107 is an oral agent that has been demonstrated to be safe in various trials thus far.

“我们不需要显示认知功能下降的逆转，正如目前的试验被认为是成功的第二阶段试验所证明的那样，如果NE3107表现出与各种单克隆抗体相当或更好的认知能力下降减慢，我们赢得了胜利，因为NE3107是迄今为止在各种试验中已被证明是安全的口服药物。

Furthermore, we do not need to demonstrate efficacy and statistical significance.

此外，我们不需要证明疗效和统计学意义。