BioVie Inc. has initiated patient enrollment for its Phase 2 SUNRISE-PD clinical trial. This trial investigates the safety and efficacy of bezisterim (NE3107) in treating motor and non-motor symptoms in early-stage Parkinson’s disease patients who have not yet received carbidopa/levodopa therapy. The company anticipates topline data in late 2025 or early 2026.
This trial is particularly noteworthy due to its focus on early intervention in Parkinson’s disease, potentially addressing the disease process before significant neuronal damage occurs. The trial’s hybrid decentralized design, incorporating remote patient participation, expands access for a population often facing geographical barriers to clinical research. This approach could serve as a valuable model for future neurological studies, potentially accelerating drug development timelines and broadening patient access to promising therapies. Investigating bezisterim’s impact on both motor and non-motor symptoms could lead to a more comprehensive treatment approach for Parkinson’s, addressing a wider range of patient needs.
SUNRISE-PD is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled trial. Approximately 60 patients will be randomized to receive either 20 mg of bezisterim or a placebo twice daily over a 12-week period. The trial incorporates at-home participation options, with study nurses conducting assessments and neurologists remotely supervising motor examinations. Funding for the trial is secured, and prominent organizations like The Michael J. Fox Foundation, Davis Phinney Foundation, and The Parkinson’s Foundation support patient recruitment.
The results of SUNRISE-PD could significantly influence the Parkinson’s disease treatment landscape. Positive data demonstrating bezisterim’s effectiveness in early-stage patients would support its potential as a disease-modifying therapy, distinct from existing symptomatic treatments. This could lead to a paradigm shift in Parkinson’s care, focusing on early intervention and disease progression modification. Furthermore, successful implementation of the decentralized trial design could encourage wider adoption of this approach, leading to more efficient and accessible clinical trials for neurological conditions.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
