BIVI BioVie Inc.

BioVie (NASDAQ:BIVI) shares fell nearly 9. 7% in premarket trading after the company reported results from its Phase 2 ADDRESS-LC trial evaluating bezisterim for neurological symptoms associated with Long COVID.

BioVie Inc (NASDAQ:BIVI, NASDAQ:BIVIW) reported topline results from its Phase 2 ADDRESS-LC trial evaluating bezisterim, an oral investigational drug for Long COVID, showing statistically significant symptom improvements in patients with high baseline disease burden. The 203-patient trial...

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

An escalating US-Canada trade dispute added to inflation concerns at the start of the holiday-shortened week

BioVie Inc (NASDAQ:BIVI, NASDAQ:BIVIW) told investors that it is preparing to advance its Phase 3 development program for bezisterim in Parkinson’s disease and has requested an End-of-Phase 2 meeting with the US Food and Drug Administration. The company is working with Parkinson’s disease...

BioVie Inc (NASDAQ:BIVI, NASDAQ:BIVIW) announced that has completed the last on-treatment visit in its Phase 2 ADDRESS-LC clinical trial evaluating bezisterim in adults with Long COVID, with topline results targeted for release before the end of September 2026. The Carson City, Nevada-based...

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