BioVie Inc. 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.

This decision to expand enrollment was informed by the following factors: The Company monitors blinded study data daily and has not observed any serious adverse events that appear to be attributed to the administered study drug (NE3107 or placebo). In addition, the safety review committee has met in September and in November to review current safety of the trial. This safety profile is consistent with what was seen in prior clinical trials showing no statistical difference in the AE rates for the treated vs.

placebo groups; The recently released topline data from a Company-supported Phase 2 exploratory biomarker study showing that patients treated with NE3107 experienced improved cognition as measured by a modified ADAS-Cog12 score, reduced TNFa (i.e., inflammation) in a manner that's correlated to improvements in cognition, reduced CSF p-tau levels and the ratio of p-tau to Aß42, and imaging findings suggestive of improved neuronal health. Despite the open-label nature of the exploratory study, the emerging data and correlations provide encouraging signs of what may see in the upcoming Phase 3 data reveal; and The current pace of patient enrollment suggest that the additional 84 patients can be enrolled in approximately two months.