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BIVI-News
BIVI-Events
BioVie Completes Last Treatment Visit of ADDRESS-LC Phase 2 Trial
BioVie announced that the last on-treatment visit of its ADDRESS-LC Phase 2 trial evaluating bezisterim for the treatment of neurological symptoms of Long COVID has been completed. The Phase 2 study is fully funded by a grant from the U.S. Department of War.
BioVie Reports Success in Parkinson's Drug Trial
BioVie announced results from the company's Phase 2 SUNRISE-PD trial evaluating its drug candidate bezisterim in early-stage Parkinson's disease. The trial successfully met prespecified endpoints and achieved its objectives, with topline results showing that bezisterim improved blood based inflammatory markers of disease, along with a broad range of biological markers associated with overall cellular health and nerve cell damage. Participants treated with bezisterim experienced greater improvements than those receiving placebo across a series of clinical outcome measures of daily living, motor symptoms, and non-motor symptoms. The majority of patients treated with bezisterim showed improvement on EPNIC-15, a composite endpoint encompassing 15 clinically relevant motor and non-motor measures of Parkinson's disease. Bezisterim was well tolerated and demonstrated a safety profile comparable to placebo.
BioVie Files $300M Mixed Securities Shelf
BioVie files $300M mixed securities shelf
BioVie Completes Last Patient Evaluation for SUNRISE-PD Phase 2 Trial
BioVie announced that the last patient evaluation visit has been completed for the company's SUNRISE-PD Phase 2 trial evaluating its drug candidate bezisterim in early-stage Parkinson's disease. "With this last patient's treatment visit completed, our team will start the study closeout process, and the Company plans announce topline results in Q3," said Cuong Do, BioVie's president and CEO. "This trial was designed to assess bezisterim's magnitude of therapeutic impact on a series of motor and non-motor endpoints so that we can finalize the design for the Phase 3 registrational trials. We look forward to unblinding the data later this year to understand the molecule's true potential."
BioVie Completes Enrollment of 60 Patients in Phase 2 SUNRISE-PD Trial
BioVie completed enrollment of 60 patients in its Phase 2 SUNRISE-PD clinical trial evaluating the safety and efficacy of bezisterim on motor and non-motor symptoms in individuals with early-stage Parkinson's disease who have not been treated with carbidopa/levodopa. SUNRISE-PD explores whether bezisterim can affect the progression of Parkinson's symptoms in patients diagnosed with PD within the past four years who need treatment for their symptoms. The trial uses a hybrid, decentralized Phase 2 trial designed to reduce common barriers to participation in PD research, including delayed diagnosis, limited mobility, geographic constraints, and access to specialized care. The study's flexible design allows participants to complete their study visits either at home or in a clinic, improving access and flexibility while maintaining rigorous data quality and centralized oversight
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