BioVie’s Phase 3 Trial Assessing NE3107 in Alzheimer’s Disease Has Fully Enrolled the Targeted 316 Patients

About this update from Biovie Inc.

[{"type":"text","content":"Company is Opting to Increase Study Size to 400 due to Fast Enrollment Pace\nCARSON CITY, Nev., Nov. 29, 2022 (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 more than 316 patients have enrolled in its Phase 3 trial, thereby achieving its trial enrollment target. Furthermore, the Company has opted to continue enrolling up to 400 patients without the pre-specified interim data analysis due to NE3107’s safety in this study to date and a faster than expected pace of study enrollment. The NM101 trial is a potentially pivotal Phase 3 randomized, double blind, placebo controlled, parallel group, multicenter study to evaluate NE3107 in patients who have mild to moderate Alzheimer's disease (NCT04669028). The study has co-primary endpoints looking at cognition using the Alzheimer’s Disease Assessment Scale-Cognitive Scale (ADAS-Cog 12) and function using the Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC). The NM101 trial protocol specified enrolling at least 316 patients equally randomized to treatment and placebo arms. The protocol also pre-specified the potential for a review by the data safety monitoring board (DSMB), in a manner that is blinded to the Company, when roughly 50% of the 316 enrolled patients have completed the study to determine if increasing enrollment of up to 400 patients might be desirable for the purpose of enhancing the probability of achieving statistical significance. The pace of enrollment increased dramatically in recent months, creating a situation where the Company finished enrolling all 316 patients before 50% of enrolled patients had completed the study. “We are pleased and encouraged by the dramatic increase in the pace of enrollment in recent months, and have decided that forgoing the interim analysis and continuing enrollment up to 400 patients is the best course for obtaining the strongest possible data set,” said Cuong Do, BioVie’s President and CEO. “We believe all 400 patients can be enrolled in the coming months , and anticipate topline results will be available before the end of 3Q2023. By taking this step we believe we have enhanced our probability for su...

More updates from Biovie Inc.