BIVI News & Events

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 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