Designing a Hybrid Trial of Bezisterim for Early-Stage Parkinson Disease: Mark Stacy, MD; Joseph M. Palumbo, MD, LFAPA, MACPsych

WATCH TIME: 7 minutes

"We're looking at the safety, benefit, and efficacy of this drug, bezisterim. But we're also looking to see if we can change the paradigm of how clinical research is done in Parkinson disease. It's my hope that we will demonstrate that this method is equal or superior to the traditional method of clinical research and that will give us a better chance to develop new drugs in the future."

Bezisterim (BioVie) is an investigational oral, blood-brain barrier, permeable compound with anti-inflammatory and insulin-sensitizing properties intended to target key biological pathways thought to drive Parkinson disease (PD) progression.¹ In a previous phase 2 study (NCT05083260), findings revealed significant improvements in morning ON symptoms and clinically meaningful improvement in motor control among patients treated with a combination of bezisterim and levodopa versus patients treated with levodopa alone. Notably, investigators observed no drug-related adverse events in the study.

The investigational therapy will also be assessed in the ongoing randomized, double-blind, placebo-controlled phase 2 SUNRISE-PD trial (NCT06757010) to treat motor and nonmotor symptoms in patients with early-stage PD. The design of this trial, was presented by senior author Joseph M. Palumbo, MD, LFAPA, MACPsych, chief medical officer at BioVie, as an awarded poster at the recently concluded 4th Annual Advanced Therapeutics in Movement and Related Disorders (ATMRD) Congress, held by the PMD Alliance from June 27-30, 2025.

After the Congress, Palumbo and lead author Mark Stacy, MD, William E. Murray Professor of Neurology in the Movement Disorders Division at the Medical University Of South Carolina, spoke with NeurologyLive^® about the design of the trial. The duo noted that the study integrates traditional site visits with home-based video assessments, aiming to reduce recruitment barriers and enhance patient access. By comparing in-person assessments with remote evaluations, the experts noted that the trial seeks to evaluate the safety and efficacy of bezisterim with the potential of establishing a new model for PD research.

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REFERENCES
1. Stacy M, Ahlem C, Reading CL, Zhang J, Palumbo JM. SUNRISE-PD: An Ongoing, Hybrid, Decentralized Phase 2 Study of Bezisterim (NE3107) in Early Parkinson’s Disease. Presented at: ATMRD; June 27-30, 2025; Washington, DC. P49.