Why Is Alzheimer's-Focused BioVie Stock Trading Lower Today?

BioVie Inc BIVI shares are trading lower after the company released an analysis of unblinded, topline efficacy data from its Phase 3 trial of NE3107 for mild to moderate Alzheimer's Disease.

The trial, initiated during the COVID-19 pandemic, enrolled 439 patients. However, the company found significant deviation from protocol violations, which led to the exclusion of all patients from 15 sites. 

Initial analysis of unblinded data from 57 per-protocol patients suggests that NE3107 demonstrates biological activity and may impact cognitive, functional, and biomarker endpoints.

Patients treated with NE3107 showed improvement compared to placebo on cognitive and functional assessments.

The company said the primary endpoint missed statistical significance due to site exclusions. 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 Clinical Dementia Rating-Sum of Boxes (CDR-SB).

The company retained three independent biostatistical consulting firms to analyze the data. The company says the unplanned exclusion of so many patients has left the trial unpowered for the primary endpoints.

Based on the efficacy signal seen in this trial, BioVie intends to work with the FDA to potentially employ the adaptive trial feature of the protocol to continue enrolling patients to achieve statistical significance. BioVie has retained a new CRO for future trials.

Price Action: BIVI shares are down 63.3% at $1.83 on the last check Wednesday.