BioVie reports positive phase 2 Parkinson's results, eyes pivotal Phase 3 trial

BioVie CEO Cuong Do joined Steve Darling from Proactive to discuss positive results from the company's 60-patient Phase 2 clinical trial of bezisterim in Parkinson's disease, which demonstrated statistically significant improvements over placebo in both motor and non-motor symptoms across multiple clinical endpoints. Do said 25% of patients treated with bezisterim experienced meaningful clinical improvement compared with 4% in the placebo group, while only 14% of treated patients showed meaningful worsening versus 46% of placebo patients. He highlighted the improvements in non-motor symptoms as especially significant, noting that current Parkinson's therapies primarily target motor impairment. Symptoms such as sleep disturbances, mood disorders, constipation, and cognitive decline often emerge years before motor symptoms, yet there are currently no approved therapies specifically addressing these aspects of the disease. The study also evaluated biomarkers associated with neurodegeneration, with bezisterim-treated patients showing a smaller increase than those receiving placebo. Do said the findings provide an encouraging early signal that a larger Phase 3 study could determine whether the treatment slows disease progression, potentially positioning bezisterim as the first therapy to modify the course of Parkinson's disease. Looking ahead, BioVie plans to hold an end-of-Phase 2 meeting with the U.S. Food and Drug Administration to discuss the design of a potentially pivotal Phase 3 registration trial. The company is also advancing a separate long COVID clinical trial, with data expected within the next 30 to 45 days. proactiveinvestors #biovieince #nasdaq #bivi #NeurodegenerativeDiseases #parkinsonsdisease #BrainHealth #BioVie #CognitionImprovement #Neuroinflammation #Biotech #ClinicalTrials #DrugDevelopment #Neurology #HealthcareInnovation #FDA #LongCOVID #Pharmaceuticals