BioVie (NASDAQ:BIVI) shares fell nearly 9.7% in premarket trading after the company reported results from its Phase 2 ADDRESS-LC trial evaluating bezisterim for neurological symptoms associated with Long COVID.
The study did not achieve statistical significance on any of its 22 clinical outcome measures in the full intent-to-treat population of 203 patients.
The trial was funded by a $13.13 million grant from the US Department of War. BioVie had previously indicated that topline results were expected before the end of September 2026.
Subgroup Analysis Shows Differences Versus Placebo
BioVie also reported results from prespecified subgroup analyses involving patients with a higher baseline symptom burden, representing approximately 78% of trial participants.
According to the company, this subgroup showed statistically significant improvements on certain measures compared with placebo. BioVie also said 21 of the trial’s 22 clinical outcome measures numerically favoured bezisterim over placebo.
The subgroup findings do not change the result for the overall intent-to-treat population, in which none of the 22 measures reached statistical significance.
Further studies would be required to determine whether the subgroup findings can be replicated and support additional clinical development.
BioVie to Discuss Results on Conference Call
BioVie scheduled a conference call for 8:30 a.m. ET to discuss the ADDRESS-LC results and the development programme for bezisterim.
The supplied information indicated that a potential future development strategy could involve further evaluation of patients with higher baseline symptom burden, although no Phase 3 programme was confirmed.
BioVie’s premarket decline came as broader US equity markets traded close to unchanged. Investors were also awaiting the Federal Reserve’s monetary policy decision, while the 10-year US Treasury yield had recently moved above 5%.
Biovie stock price
