BioVie Inc. announced that a poster detailing the decentralized design and patient experience of its Phase 2 SUNRISE-PD clinical trial, evaluating bezisterim (NE3107) for early Parkinson’s disease, will be presented at the Advanced Therapeutics in Movement & Related Disorders Congress. The trial employs a hybrid decentralized model allowing patients to participate from home or a clinical site, with remote neurological assessments. If successful, participants may qualify for a longer-term safety study.
This trial design is potentially groundbreaking for Parkinson’s research. Decentralized trials can improve patient access, particularly for those in rural areas or with mobility issues, leading to more diverse and representative study populations. This model may also accelerate recruitment and shorten trial timelines, crucial for bringing new therapies to patients faster. The remote assessment aspect offers further convenience, minimizing the burden on patients and caregivers.
SUNRISE-PD is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study spanning 20 weeks. Bezisterim targets inflammation and insulin resistance, factors implicated in Parkinson’s progression. Prior Phase 2 data for bezisterim, combined with levodopa, demonstrated improvements in motor control without drug-related adverse events. BioVie is also investigating bezisterim for long COVID and Alzheimer’s disease.
A successful decentralized trial could establish a new standard for Parkinson’s research, fostering broader participation and faster development timelines. Positive results for bezisterim could offer a much-needed new therapeutic approach, particularly given the limitations of existing long-term levodopa treatments. This trial represents an important step towards improving the lives of individuals living with this debilitating disease.
Source link: https://www.globenewswire.com/news-release/2025/06/24/3104649/0/en/BioVie-to-Present-Overview-of-Phase-2-SUNRISE-PD-Trial-at-the-Advanced-Therapeutics-in-Movement-Related-Disorders-Congress.html
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.
