BioVie Phase 2 Long COVID Trial Misses Primary Endpoint

BioVie Inc. shares rose 3.5% after the clinical-stage company reported that its Phase 2 trial of bezisterim missed statistical significance in the broad intent-to-treat population, while pre-specified high-symptom subgroups showed measurable improvements.

"To our knowledge, this is the first time a drug candidate has shown the ability to help patients improve across these persistent Long COVID symptoms," said Cuong Do, BioVie's President and CEO, in a company press release.

Clinical Trial Design and ADDRESS-LC Results

The 203-patient ADDRESS-LC trial evaluated bezisterim for neurological and systemic symptoms associated with Long COVID. According to the trial announcement, the drug did not achieve statistical significance on any of its 22 clinical endpoints in the overall intent-to-treat group, though 21 of the 22 endpoints displayed numerical trends favoring the drug over placebo.

However, pre-specified subgroup analyses agreed upon with the Food and Drug Administration prior to unblinding revealed distinct efficacy in participants with a higher baseline symptom burden. Accounting for roughly 78% of trial participants, this high-symptom cohort demonstrated statistically significant gains in fatigue, post-exertional malaise, and objective cognitive testing.

Safety Profile and Grant Funding

Bezisterim also maintained a favorable safety profile throughout the study period. Treatment-emergent adverse events occurred in 41.6% of patients receiving bezisterim, compared to 55.9% in the placebo arm, with zero serious adverse events reported among participants taking the study drug, according to an Investing.com report.

The ADDRESS-LC clinical evaluation was fully funded by a $13.13 million grant awarded through the Peer-Reviewed Medical Research Program.

Market Response and Phase III Plans

Following the topline data release, BioVie (BIVI) stock traded at $1.78, representing a 3.49% increase from its previous close of $1.72, according to Finnhub market data.

"These results are among the most promising we have seen in this field so far and clearly warrant progressing to a confirmatory Phase III trial," said Michael Peluso, MD, MHS, Associate Professor of Medicine at the University of California, San Francisco.

BioVie management indicated plans to utilize the positive high-symptom subgroup findings to design and launch a confirmatory Phase III trial targeting persistent neurological manifestations of Long COVID.