BioVie Gets Approval For $12.6 Mln Grant To Initiate Phase 2 Trial Of Bezisterim For Long COVID

(RTTNews) - BioVie Inc. (BIVI) announced on Monday that it has received all necessary scientific approvals for an additional $12.6 million in grant funding from the U.S. Department of Defense, to initiate a planned Phase 2 trial of bezisterim focused on long COVID.

The U.S. Army Medical Research and Development Command, Office of Human Research Oversight (OHRO), has also approved the company's plan to study Bbezisterim for neurological symptoms related to long COVID. This follows the FDA's confirmation in August 2024 that the study is Safe to Proceed.

The Phase 2 trial is set to begin in early 2025 and will involve about 200 patients in a randomized, placebo-controlled format. The trial aims to evaluate the safety, tolerability, and potential effectiveness of Bezisterim in alleviating neurocognitive symptoms of long COVID over a treatment period of three months.

Bezisterim is designed to cross the blood-brain barrier and works on inflammation through NF-kB activation, targeting a suspected root cause of long COVID symptoms.