BioVie advances Phase 3 Parkinson’s drug program

• BioVie advanced regulatory discussions with the FDA for a Phase 3 trial of bezisterim in Parkinson’s disease.
• The company plans to discuss a Phase 3 design using MDS-UPDRS Part III as the primary endpoint and MDS-UPDRS Part I as an additional endpoint.
• BioVie said Phase 2 SUNRISE-PD results support further evaluation of bezisterim, with a potential Phase 3 trial targeting about 175 patients.

BioVie (NASDAQ:BIVI) advanced regulatory discussions with the U.S. FDA for a Phase 3 development program evaluating bezisterim in Parkinson’s disease following Phase 2 SUNRISE-PD results.

The company said it is working with Parkinson’s disease clinical development experts to finalize a Phase 3 trial design that is expected to include MDS-UPDRS Part III as the primary endpoint.

BioVie said the Phase 3 program may include approximately 175 patients using an enrichment strategy based on Phase 2 findings showing patients with higher inflammation levels experienced greater treatment benefits.

In the SUNRISE-PD trial involving 57 patients, BioVie reported that patients with elevated inflammatory markers showed statistically significant differences versus placebo across MDS-UPDRS Parts I, II, and III, as well as total MDS-UPDRS scores, though the findings require validation in larger studies.

BioVie develops investigational therapies for neurological and neurodegenerative diseases, including Parkinson’s disease, Alzheimer’s disease, and Long COVID, with bezisterim being evaluated as an oral treatment targeting inflammation-related pathways.