BioVie Inc. (BIVI) announced on Monday that it has secured all necessary scientific approvals for an additional $12.6 million in grant funding from the U.S. Department of Defense to initiate a Phase 2 trial of bezisterim, targeting long COVID.
The U.S. Army Medical Research and Development Command, Office of Human Research Oversight (OHRO), has also given its nod to the company's plan to investigate bezisterim for neurological symptoms associated with long COVID. This follows the FDA's confirmation in August 2024 that the study is safe to proceed.
Scheduled to commence in early 2025, the Phase 2 trial will involve approximately 200 patients in a randomized, placebo-controlled format. The trial's objectives are to assess the safety, tolerability, and potential efficacy of bezisterim in mitigating neurocognitive symptoms of long COVID over a three-month treatment period.
Bezisterim is formulated to cross the blood-brain barrier and combats inflammation through NF-kB activation, addressing a suspected underlying cause of long COVID symptoms.
