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 clinical development experts to finalize the design of a Phase 3 trial.
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 clinical-stage company is developing therapies for neurological and neurodegenerative diseases.
BioVie Inc. (BIVI) Discusses Bezisterim Mechanism of Action and SUNRISE-PD Phase II Trial Design Transcript
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.
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 SUNRISE-PD trial was a multicenter, randomized, double-blind, placebo-controlled study in patients with early-stage Parkinson's disease who had not previously been treated with carbidopa/levodopa.
BioVie Inc. (BIVI) Discusses Clinical Updates on Bezisterim and BIV201 for Parkinson's, Alzheimer's, and Ascites Transcript
BioVie Inc (NASDAQ:BIVI, NASDAQ:BIVIW) earlier this week announced that its Phase 2 long COVID trial evaluating bezisterim has achieved full enrollment, marking an important milestone for the biotechnology company as it advances a potential treatment for patients suffering persistent post-COVID symptoms. Speaking with Proactive, CEO Cuong Do said the study enrolled more than 200 long COVID patients with support from major medical institutions including Yale, Mount Sinai, Mayo Clinic and Stanford.
BioVie Inc (NASDAQ:BIVI, NASDAQ:BIVIW) said on Tuesday it has completed enrollment in its ADDRESS-LC Phase 2 clinical trial evaluating bezisterim for the treatment of neurological symptoms of Long COVID, with topline data expected later this summer. The trial, fully funded by a grant from the US Department of War, is testing whether bezisterim can address neurological and neuropsychiatric symptoms associated with Long COVID, including fatigue, cognitive dysfunction, post-exertional malaise and sleep disturbance.
BioVie Inc (NASDAQ:BIVI, NASDAQ:BIVIW) has completed the last patient evaluation visit in its SUNRISE-PD Phase 2 clinical trial testing drug candidate bezisterim in early-stage Parkinson's disease, with topline results expected in the third quarter. The NASDAQ-listed clinical-stage company said the completion of the final visit marks the start of the study closeout process.
BioVie Inc. (BIVI) Discusses Bezisterim's Mechanism of Action and Its Potential in Addressing Parkinson's Disease Pathology Transcript
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 million Americans are affected by long COVID, with symptoms ranging from brain fog and fatigue to more severe functional impairments.
BioVie Inc (NASDAQ:BIVI, NASDAQ:BIVIW) said on Tuesday an abstract from its mid-stage study of experimental Parkinson's disease treatment bezisterim has been accepted for presentation at an upcoming neurology conference. The abstract, based on the company's SUNRISE-PD trial evaluating bezisterim in patients with early Parkinson's disease, will be presented at the American Academy of Neurology Annual Meeting later this week.