Phase 2 SUNRISE-PD Trial to Test BioVie‘s Bezisterim for Early-Stage Parkinson Disease

Cuong Do, MBA

(Credit: BioVie)

At the 4th Annual Advanced Therapeutics in Movement and Related Disorders (ATMRD) Congress, held by the PMD Alliance from June 27-30, 2025, researchers presented the design of the ongoing randomized, double-blind, placebo-controlled phase 2 SUNRISE-PD trial (NCT06757010), assessing the safety and efficacy of investigational bezisterim (BioVie) on motor and nonmotor symptoms in patients with early-stage Parkinson disease (PD). The trial aims to address barriers in care access and study participation such as delayed diagnosis, limited mobility, and geographic constraints that patients with PD may often face.¹

SUNRISE-PD, a uniquely built trial, will have a hybrid decentralized design that will last 20 weeks from the initial screening phase to the safety follow up.² Eligible participants must be aged between 41 and 80 years who have been diagnosed in the last 4 years and have not yet initiated treatment with carbidopa/levodopa or other dopamine receptor agonists. The trial design includes in-home visits conducted by nurses with neurologist oversight through video and remote assessment of motor symptoms using a modified MDS-UPDRS Part III scale assessed by a centralized rating committee.

“SUNRISE-PD represents the future of clinical trial design one that meets people where they are and makes participation possible without compromising scientific rigor,” Cuong Do, MBA, president and CEO at BioVie, said in a statement.¹ “By combining an innovative therapeutic approach with a decentralized model, we are exploring the potential of bezisterim to impact the course of Parkinson’s disease and set a precedent for how studies can be more inclusive, accessible and patient-focused.”

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Bezisterim 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 PD progression.³ A previous phase 2 study (NCT05083260) showed significant improvements in morning ON symptoms and clinically meaningful improvement in motor control in patients treated with a combination of bezisterim and levodopa versus patients treated with levodopa alone. Importantly, investigators observed no drug-related adverse events.

In Long COVID, it has been hypothesized that bezisterim may help alleviate neurological symptoms such as fatigue and cognitive dysfunction. Persistent viral spike proteins are thought to activate the TLR-4/NFκB pathway, leading to increased expression of inflammatory cytokines. The phase 2 ADDRESS-LC trial of bezisterim (NCT06847191) is an ongoing, randomized, double-blind, placebo-controlled, multicenter study enrolling approximately 200 patients with Long COVID to assess the safety, tolerability, and potential efficacy of the treatment for 3 months in reducing neurocognitive symptoms associated with the condition, including brain fog and fatigue.⁴

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REFERENCES
1. BioVie Highlights Patient-Centric Design of SUNRISE-PD Trial at Advanced Therapeutics in Movement & Related Disorders® Congress (ATMRD). News Release. BioVie. Published June 26, 2025. Accessed June 26, 2025. https://investors.bioviepharma.com/news/news-details/2025/BioVie-Highlights-Patient-Centric-Design-of-SUNRISE-PD-Trial-at-Advanced-Therapeutics-in-Movement--Related-Disorders-Congress-ATMRD/default.aspx
2. BioVie to Present Overview of Phase 2 SUNRISE-PD Trial at the Advanced Therapeutics in Movement & Related Disorders® Congress. News Release. BioVie. Published June 26, 2025. Accessed June 26, 2025. https://investors.bioviepharma.com/news/news-details/2025/BioVie-to-Present-Overview-of-Phase-2-SUNRISE-PD-Trial-at-the-Advanced-Therapeutics-in-Movement--Related-Disorders-Congress/default.aspx
3. 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.
4. BioVie Enrolls First Patient in ADDRESS-LC Clinical Trial Assessing Novel Anti-Inflammatory Candidate Bezisterim for the Treatment of Neurological Symptoms Associated with Long COVID. News release. BioVie. May 15, 2025. Accessed June 26, 2025. https://investors.bioviepharma.com/news/news-details/2025/BioVie-Enrolls-First-Patient-in-ADDRESS-LC-Clinical-Trial-Assessing-Novel-Anti-Inflammatory-Candidate-Bezisterim-for-the-Treatment-of-Neurological-Symptoms-Associated-with-Long-COVID/default.aspx