Proactive - Interviews for investors podcast

BioVie advances Parkinson’s, long COVID, and liver disease programs ahead of 2026

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BioVie CEO Cuong Do joined Steve Darling from Proactive to provide an update on the company’s recent progress across its two lead drug candidates, Bezisterim and BIV201, as BioVie positions itself for multiple clinical and regulatory catalysts in 2026. Bezisterim, an anti-inflammatory compound that blocks tumor necrosis factor alpha (TNF-α), is being evaluated across several indications, including Parkinson’s disease, long COVID, and Alzheimer’s disease. Do highlighted that the compound has delivered encouraging signals in prior studies, including improvements in muscle control and cognitive function, as well as evidence suggesting a slowing of biological aging. Building on these results, BioVie has launched a new clinical trial enrolling 60 patients with earlier-stage Parkinson’s disease to evaluate Bezisterim as a standalone therapy. The goal of the study is to assess the drug’s potential disease-modifying effects when administered earlier in the disease course. Topline data from this trial are expected in April or May of 2026. In parallel, BioVie is advancing a separate, larger clinical program targeting long COVID. The company is conducting a 200-patient trial designed to evaluate Bezisterim’s ability to address persistent inflammatory mechanisms believed to drive many long COVID symptoms. Enrollment for this study is expected to be completed by February 2026. The trial is supported by a $13 million grant awarded to BioVie, underscoring the growing recognition of inflammation as a key contributor to long COVID. Do also provided an update on BioVie’s second lead candidate, BIV201, which is being developed to treat ascites associated with late-stage liver disease. The company’s Phase 2 trial of BIV201 was stopped early after interim data showed the drug reduced fluid accumulation by more than 50%, a clinically meaningful outcome in a difficult-to-treat patient population. Following discussions with the U.S. Food and Drug Administration, BioVie has now received feedback and authorization to advance BIV201 directly into a single Phase 3 clinical trial, streamlining the development pathway. Looking ahead, Do emphasized that BioVie expects 2026 to be a transformational year, with multiple clinical data readouts across programs and the potential initiation of a pivotal Phase 3 study. “2026 will be a big catalyst year for us,” he said, highlighting the breadth of opportunities across the company’s pipeline. proactiveinvestors #biovieince #nasdaq #bivi #alzheimersdisease #dementia #Alzheimers #Dementia #NeurodegenerativeDiseases #BrainHealth #BioVie #CognitionImprovement #Neuroinflammation #SocialImpact #DementiaAwareness #ElderlyCare #Neuroscience #MemoryImprovement #AlzheimersResearch #HealthCrisis #DementiaSupport #BrainScience #GlobalHealth #AlzheimersSolution #Caregivers #HealthyAging #MentalHealth #MedicalResearch #DementiaPrevention #Neurology #WorldAlzheimersDay #invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews

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