BioVie says FDA aligns with mid-stage Parkinson’s disease trial

hapabapa BioVie ( NASDAQ: BIVI ) added ~15% in early premarket trading on Thursday after the company said that the U.S. FDA aligned with its plans for its mid-stage SUNRISE-PD trial targeted at its Parkinson’s disease candidate, bezisterim.

Following FDA feedback on the trial design, BioVie ( BIVI ) noted that the SUNRISE-PD had already included a secondary endpoint, incorporating a clinical measure the FDA had recommended as a primary endpoint. Therefore, “BioVie believes it can proceed with the SUNRISE-PD trial as planned without protocol amendments,” the company added. As a result, the company said it is currently working on trial start-up activities to begin patient screening in Q4 2024.

The 60-subject Phase 2 trial is designed to evaluate bezisterim’s impact on Parkinson’s disease symptoms over 20 weeks, from the initial screening to the safety follow-up. SUNRISE-PD, a placebo-controlled trial, is expected to target newly diagnosed patients with Parkinson’s disease. More on BioVie Inc.

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