BioVie Inc (NASDAQ:BIVI, NASDAQ:BIVIW) earlier this week announced that its Phase 2 long COVID trial evaluating bezisterim has achieved full enrollment, marking an important milestone for the biotechnology company as it advances a potential treatment for patients suffering persistent post-COVID symptoms.
Speaking with Proactive, CEO Cuong Do said the study enrolled more than 200 long COVID patients with support from major medical institutions including Yale, Mount Sinai, Mayo Clinic and Stanford. Patients were randomized between placebo and bezisterim treatment arms to evaluate the drug candidate’s ability to address symptoms such as brain fog, malaise and fatigue.
Do said long COVID remains a major unmet medical need despite broader public attention shifting away from the pandemic. He noted that an estimated 17 million Americans continue to suffer lingering symptoms following infection, while approximately 3 million patients have experienced severe enough symptoms to disrupt employment and daily functioning.
The company believes inflammation may play a central role in long COVID pathology. Do explained that fragments of viral proteins may remain circulating in some patients even after the active infection has resolved, triggering ongoing immune responses and inflammation.
Those 17 million are believed to have continuing circulating in their body fragments of the spike protein and the envelope protein, Do told Proactive.
BioVie believes bezisterim may help regulate inflammatory mechanisms associated with these persistent symptoms. The company also highlighted that it received a $13 million grant to support exploration of the therapy in long COVID patients, underlining growing institutional interest in the condition.
Investors are now expected to focus on the upcoming data catalyst, with top-line trial results anticipated by late October or potentially as early as September. Positive efficacy signals could significantly strengthen BioVie’s regulatory and commercial positioning.
Do said the company intends to pursue discussions with the FDA regarding potential accelerated approval or emergency use authorization pathways if the data supports the therapy’s benefit-risk profile.
He added that even limited penetration into the most severely affected patient population could represent a substantial commercial opportunity. According to Do, targeting only a fraction of the estimated 3 million severely impacted patients could potentially translate into a product with annual sales exceeding $10 billion.