BioVie, Inc. is a biopharmaceutical company, which engages in discovery, development, and marketing drug therapies for neurological and neurodegenerative disorders and liver disease. The company was founded on April 10, 2013 and is headquartered in Carson City, NV.
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- BioVie's Phase 2 ADDRESS-LC trial of oral bezisterim missed statistical significance on all 22 endpoints in the full 203-patient intent-to-treat Long COVID population. - Pre-specified subgroups with high baseline fatigue, cognitive impairment or post-exertional malaise showed statistically significant improvements, representing about 78% of participants. - Bezisterim's safety profile was similar to placebo, with 41.6% of treated patients reporting treatment-emergent adverse events versus 55.9% on placebo. - BioVie shares fell roughly 9.7% premarket, and the company plans to advance bezisterim into a confirmatory Phase 3 trial.
- BioVie will host a virtual KOL event on May 7, 2026, featuring Dr. Suzanne de la Monte to discuss bezisterim's mechanism of action in addressing neurodegenerative disease pathology. - The company's SUNRISE-PD Phase 2 trial is evaluating bezisterim as a monotherapy for motor and non-motor symptoms in Parkinson's patients not treated with carbidopa/levodopa, with topline results expected mid-2026. - Bezisterim is an oral small molecule that crosses the blood-brain barrier and selectively inhibits inflammation-driven ERK and NF-κB pathways while reducing insulin resistance without suppressing immune function. - Previous Phase 2 data showed Parkinson's patients taking bezisterim with levodopa demonstrated better motor control and fewer morning symptoms compared to levodopa alone, with minimal side effects.
- BioVie Inc. appointed Amy S. Chappell, MD, FAAN, and Kameel D. Farag to its Board of Directors to support the company's neurological and liver disease drug development programs. - Dr. Chappell brings 25 years of CNS drug development experience at Eli Lilly, including FDA approvals for Cymbalta in fibromyalgia and musculoskeletal pain indications. - The appointments coincide with BioVie's ongoing Phase 2 trials of bezisterim for early Parkinson's disease and long COVID, plus advancing Alzheimer's disease and liver cirrhosis programs. - Farag's financial expertise includes securing over $150 million in financing at Aspen Neuroscience and scaling operations at major pharmaceutical companies like Ionis and Amgen.
- BioVie has enrolled the first patient in its Phase 2 ADDRESS-LC trial evaluating bezisterim for neurological symptoms of long COVID, with topline data expected in the first half of 2026. - Long COVID affects approximately 20 million adults in the US alone, with 10-30% of COVID-19 patients experiencing persistent symptoms including fatigue and cognitive impairment, yet no FDA-approved treatments exist. - Bezisterim targets neuroinflammation by modulating NF-κB activation and TNF-α production, pathways implicated in both long COVID and neurodegenerative diseases like Alzheimer's and Parkinson's.
- BioVie has enrolled the first patient in its Phase 2 SUNRISE-PD trial evaluating bezisterim, an anti-inflammatory and insulin-sensitizing drug candidate, in early-stage Parkinson's disease patients who haven't received carbidopa/levodopa treatment. - The innovative trial features a hybrid decentralized design allowing patients to participate remotely from home, with support from major foundations including The Michael J. Fox Foundation, potentially expanding access to clinical research. - Bezisterim targets underlying inflammation and insulin resistance mechanisms implicated in Parkinson's disease progression, offering a potential alternative to traditional dopamine-replacement therapies that only provide symptomatic relief.
- Vivani Medical plans to spin off its Cortigent neurostimulation division as an independent Nasdaq-listed company by Q3 2025, allowing each entity to focus on their distinct therapeutic areas. - Cortigent's technology includes the Orion® artificial vision system for blindness, which completed a 6-year clinical study in 2024 with promising results, and applications for stroke recovery. - Post-spinoff, Vivani will concentrate exclusively on developing its proprietary NanoPortal™ GLP-1 implants for chronic weight management and type 2 diabetes with once or twice-yearly administration.
• Over 120 Alzheimer's Disease treatment therapies are under development by 110+ companies globally, ranging from preclinical to marketed phases. • Emerging therapies like NRDN-201, ST-501, and KarXT are in various clinical trial phases, showing potential for significant market impact. • MapLight Therapeutics initiated a Phase 1 trial for ML-007/PAC, targeting schizophrenia and Alzheimer's disease psychosis, with Phase 2 trials planned. • The FDA granted conventional approval to Leqembi (lecanemab-irmb), marking the first amyloid beta-directed antibody to transition from accelerated approval.
- BioVie Inc. will present the design of its Phase 2 trial of bezisterim for Long COVID at the Demystifying Long COVID International Conference. - The Phase 2 study is a double-blind, randomized, placebo-controlled, multicenter trial involving approximately 200 patients. - Bezisterim's efficacy in reducing neurocognitive symptoms associated with Long COVID will be evaluated over a 3-month treatment period. - The trial is fully funded by a $13.1 million grant from the U.S. Department of Defense.
- Research in the seven major markets (7MM) increasingly prioritizes disease-modifying therapies (DMTs) and treatments for non-motor symptoms of Parkinson's disease. - 66% of the 93 products in Phase I-III development are prospective neuroprotective agents or DMTs targeting mechanisms like alpha-synuclein aggregation and neuroinflammation. - 26% of pipeline DMTs target alpha-synuclein aggregation, though this approach has faced setbacks, highlighting the complexity of Parkinson's pathogenesis. - There is also growing research into treatments for non-motor symptoms, with 3% of the pipeline specifically targeting Parkinson's disease dementia and psychosis.
- Clinical research in Parkinson's disease (PD) is increasingly focused on disease-modifying therapies (DMTs) to address unmet needs beyond motor symptom management. - 66% of the 93 products in Phase I-III development target key mechanisms like alpha-synuclein aggregation and neuroinflammation to slow disease progression. - Late-stage DMTs include Annovis Bio’s Posiphen and BioVie’s Triolex, targeting alpha-synuclein inhibition and inflammatory mediators, respectively. - Research also emphasizes non-motor symptoms, with agents like Cerevance’s solengepras and IRLAB’s Pirepemat targeting postural instability and PD-dementia.
