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BioVie Announces Alignment with FDA on Clinical Trial to Assess Bezisterim in Parkinson’s Disease
SUNRISE-PD to evaluate the effect of bezisterim (NE3107) on motor and non-motor symptoms in ~60 patients with Parkinson’s disease who are naïve to
About this update from Biovie Inc.
[{"type":"text","content":"SUNRISE-PD to evaluate the effect of bezisterim (NE3107) on motor and non-motor symptoms in ~60 patients with Parkinson’s disease who are naïve to carbidopa/levodopa Company engaged in trial start-up activities and plans to initiate patient screening Q4 2024 CARSON CITY, Nev., Aug. 08, 2024 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that it has achieved alignment with the Food and Drug Administration (FDA) on its upcoming SUNRISE-PD trial in Parkinson’s disease (“PD”). As a result, the Company is conducting trial start-up activities with a view to initiate patient screening in Q4 2024. The Company submitted the SUNRISE-PD clinical trial protocol to the FDA for comments, and the agency provided a single, actionable comment recommending the inclusion of the Part II score from the Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale (“MDS-UPDRS”) as a primary endpoint for potential future registrational filings. As this metric is already included as a secondary endpoint within the current trial design, BioVie believes it can proceed with the SUNRISE-PD trial as planned without protocol amendments. \"The SUNRISE-PD trial focuses on the second of two objectives we have in developing bezisterim for Parkinson’s disease, which is to improve upon the motor experiences in patients’ daily living,” said Cuong Do, BioVie’s President and CEO. “Our Phase 2a trial demonstrated that bezisterim in conjunction with levodopa may dramatically improved motor control for patients with moderate to severe symptoms of Parkinson’s disease. The Phase 2 SUNRISE-PD trial is designed to explore bezisterim’s impact on symptoms of Parkinson’s disease in patients who need medication for the first time. This Phase 2 study intends to address the newly diagnosed patient population, which in conjunction with our earlier trial, could establish bezisterim’s applicability for the total Parkinson’s patient population and provide a foundation for a disease progression study, which is the ultimate objective of the PD program. We are currently engaged in trial start up preparations, and hope to initiate patient screening in Q4 of 2024.\" About the SUNRISE-...