BioVie’s lead therapy candidate shows improvement in key long COVID symptoms

BioVie CEO Cuong Do joined Steve Darling from Proactive to discuss what the company believes is a significant breakthrough in the treatment of long COVID, reporting that its lead drug candidate, Bezisterim, became the first therapy to demonstrate improvements across the three hallmark symptoms of the condition—fatigue, malaise and brain fog—in a well-controlled clinical trial. Do noted that the National Institutes of Health (NIH) RECOVER Initiative has supported eight clinical studies evaluating 13 different interventions for long COVID, yet none have demonstrated meaningful effectiveness to date. Against that backdrop, he said BioVie’s results stand out as an important milestone in the search for therapies targeting the complex and often debilitating condition. According to Do, the trial delivered three major insights into long COVID and how it may be treated. First, the study confirmed that long COVID is highly heterogeneous, meaning patients experience symptoms very differently. Only about 15% of participants entered the study with severe levels of all three major symptoms, while roughly 20% were not significantly affected by any of them. Second, the data showed that patients must have a meaningful level of symptom severity at baseline in order to demonstrate measurable improvement. This finding may help guide future trial designs and patient selection strategies. Third, and most importantly, patients with a high symptom burden experienced clinically meaningful and statistically significant improvements. Participants suffering from severe fatigue saw improvements in fatigue-related measures, those with pronounced malaise experienced gains in both malaise and cognitive function, and patients with severe brain fog demonstrated measurable improvements in cognitive impairment endpoints. Looking ahead, Do said BioVie expects biomarker data from the study within the next several months. The company hopes those results will provide further insight into the biological mechanisms behind Bezisterim’s effects and help validate the therapeutic approach. Following the biomarker analysis, BioVie plans to request an end-of-Phase 2 meeting with the U.S. Food and Drug Administration to discuss the design of a Phase 3 trial. The company is also pursuing grant funding opportunities to help support the next stage of development for its long COVID program. Beyond long COVID, BioVie continues to advance Bezisterim as a potential treatment for Parkinson’s disease. Do said the company has been working closely with clinical experts to finalize the design of a registrational Phase 3 study and believes it has identified the appropriate endpoints, study size and duration needed to demonstrate the drug’s potential to address both motor and non-motor symptoms of Parkinson’s. He added that Bezisterim could potentially become the first therapy capable of not only improving symptoms but also modifying disease progression. BioVie expects to receive formal FDA feedback on its Phase 3 Parkinson’s trial design before the end of the year. proactiveinvestors #biovieince #nasdaq #bivi #Bezisterim #LongCOVID #Healthcare #Biotech #ClinicalTrials #BrainFog #Fatigue #MedicalResearch #ParkinsonsDisease #DrugDevelopment #FDA #Biotechnology #LifeSciences #HealthcareInnovation