For years, the hunt for a Parkinson's disease-modifying drug came down to one protein: alpha-synuclein. Clear it out, the thinking went, and you slow the disease. That bet hasn't paid off yet. Now a growing slice of the industry is chasing a different culprit: inflammation in the brain...

BioVie used an endpoint called EPNIC-15, which is not well known and only appears to be referenced in papers by the company itself.

BioVie Inc (NASDAQ:BIVI, NASDAQ:BIVIW) said its drug candidate bezisterim met the prespecified endpoints of a Phase 2 trial in early-stage Parkinson's disease, with patients showing improvements in blood-based inflammatory markers and a range of clinical outcomes compared with placebo. The...

BioVie Inc (NASDAQ:BIVI, NASDAQ:BIVIW) 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

BioVie Inc (NASDAQ:BIVI, NASDAQ:BIVIW) earlier this week outlined progress in its clinical program targeting long COVID, highlighting both the scale of the unmet need and the potential for a first-in-class treatment. In an interview with Proactive, CEO Cuong Do said that approximately 17...

BioVie CEO Cuong Do joined Steve Darling from Proactive to provide an update on the company’s ongoing clinical efforts targeting long COVID, a condition that continues to affect an estimated 17 million Americans despite the acute phase of the COVID-19 pandemic having subsided. Do emphasized that long COVID remains a significant and persistent public health challenge, with many patients experiencing debilitating symptoms such as brain fog, chronic fatigue, and general malaise that can severely impact daily functioning and quality of life. He noted that unlike the initial viral infection, long COVID appears to involve lingering viral protein fragments or related biological remnants that may continue to stimulate the immune system even after the virus has been cleared from the body. This ongoing immune activation is believed to contribute to sustained inflammation, which in turn may drive the neurological and systemic symptoms associated with the condition. BioVie Inc. is focusing its research efforts specifically on addressing these central nervous system-related symptoms through a targeted therapeutic approach. Do highlighted that the company’s program is supported by a $13 million clinical research grant, underscoring both the importance and urgency of developing effective treatments in this area. He also noted that BioVie is uniquely positioned in this space, stating that it is “the only company, nonprofit, any kind of organization to have received a grant to do this,” reinforcing the distinct nature of its clinical work. The company’s clinical trial is now nearing completion of patient enrollment, with top-line data expected by the end of the summer. This represents a key near-term milestone for the program as it moves toward evaluating efficacy and safety outcomes. Importantly, Do pointed out that there are currently no approved therapies specifically designed to treat long COVID, positioning BioVie’s program as a potential first-in-class treatment option in a space with significant unmet medical need. He expressed optimism about the trial’s progress and the potential impact of a successful outcome for patients who are still unable to return to normal daily activities or work due to lingering symptoms. proactiveinvestors #biovieince #nasdaq #bivi #LongCOVID #PostCOVID #ChronicFatigue #BrainFog #Neuroinflammation #ClinicalTrials #Biotech #CNSResearch #HealthcareInnovation #MedicalResearch #PublicHealth #Inflammation #DrugDevelopment #UnmetNeed