BioVie reports topline Phase 2 ADDRESS-LC results for bezisterim in Long COVID, showing statistically significant benefits in pre-specified subgroups with high baseline symptom burden such as fatigue, cognitive impairment, and post-exertional malaise.

The Phase 2 trial was randomized, double-blind, placebo-controlled with 203 patients and evaluated 22 exploratory endpoints since there was no single primary endpoint.

In the overall intent-to-treat population, bezisterim trended favorably across 21 of 22 measures but did not reach statistical significance.

The press release includes forward-looking statements and risk disclosures, along with references and media/investor contact information.

BioVie shares fell about 16% on the news, reflecting bearish market reaction to the topline data and ongoing news flow.

Investors were advised to monitor ClinicalTrials.gov for forthcoming top-line updates once disclosed.

BioVie plans a conference call at 8:30 a.m. EDT to discuss results and host a live Q&A with management, with additional details available on the company site.

The company indicated it may proceed to a confirmatory Phase 3 trial if warranted by the ADDRESS-LC findings.

Because the study is framed as proof-of-concept rather than a registrational trial, weak or ambiguous results could pressure the stock, with markets comparing readouts to other neurology and inflammation programs.

The trial is funded by a $13.13 million DoD PRMRP award, following a planning grant of $499,200.

BioVie notes a large Long COVID patient population (15–20 million in the U.S.) with no FDA-approved treatments, and plans to advance bezisterim to Phase 3.

Safety and tolerability were similar to placebo, with 41.6% of bezisterim patients experiencing at least one adverse event versus 55.9% on placebo and no serious adverse events in the bezisterim arm.