BioVie Inc. has initiated patient enrollment in its Phase 2 SUNRISE-PD clinical trial evaluating bezisterim (NE3107) in patients with early Parkinson's disease who have not yet been treated with carbidopa/levodopa. The first patient has been enrolled in the study, with topline data expected in late 2025 or early 2026.
The trial aims to assess the safety and efficacy of bezisterim, an anti-inflammatory and insulin-sensitizing drug candidate, on both motor and non-motor symptoms in early-stage Parkinson's disease patients. This follows promising results from an earlier Phase 2a trial in patients with moderate to severe Parkinson's disease symptoms.
"Based on promising findings from our earlier Phase 2a trial in patients with moderate to severe symptoms of Parkinson's disease, we've designed the SUNRISE-PD trial to explore bezisterim's impact at an earlier stage with patients needing to go on therapy for the first time to manage their symptoms," said Cuong Do, BioVie's President and CEO.
Novel Mechanism Targeting Underlying Disease Processes
Parkinson's disease is a progressive neurodegenerative disorder characterized by the loss of dopamine-producing neurons in the substantia nigra. While traditional treatments like levodopa provide symptomatic relief by replenishing dopamine levels, they do not modify disease progression and can lead to complications with long-term use, including motor fluctuations and dyskinesia.
Bezisterim represents a different approach by targeting inflammation and insulin resistance, which emerging research suggests play critical roles in the onset and progression of Parkinson's disease. The drug is orally bioavailable, blood-brain barrier permeable, and works by binding to ERK and selectively modulating NF-κB activation and TNF-α production.
Dr. Mark Stacy, Professor of Neurology at Medical University of South Carolina and senior clinical advisor of the SUNRISE-PD trial, explained: "A growing body of research suggests that chronic inflammation and insulin resistance play a critical role in the onset and progression of Parkinson's disease. By targeting these two underlying mechanisms, bezisterim may offer a novel therapeutic approach distinct from current treatments."
Innovative Decentralized Trial Design
SUNRISE-PD is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled trial with a hybrid decentralized design lasting 20 weeks from screening to safety follow-up. During the 12-week double-blind phase, approximately 60 patients will be randomized 1:1 to receive either 20 mg of bezisterim or placebo twice daily.
What sets this trial apart is its decentralized approach, allowing patients to participate either completely from home or at a clinical site. For at-home participants, study nurses will visit to complete assessments with remote assistance from neurologists who will supervise administration of a modified MDS-UPDRS Part III examination via video. These sessions will be recorded for review and scoring by a central rating committee.
"The Parkinson's Foundation is pleased to see BioVie shares our goal of increased patient access to clinical trials with their recruitment for the SUNRISE-PD trial, which allows patients to participate remotely through a decentralized trial site in addition to standardized sites," said James Beck, PhD, Chief Scientific Officer of the Parkinson's Foundation. "By offering a remote participation option, this study is expanding access to clinical research for more people living with Parkinson's and actively lowering the all-too-common barrier of geography to research participation."
Strong Foundation Support
The trial is fully funded and enrollment is being supported by leading advocacy groups in the field, including The Michael J. Fox Foundation, Davis Phinney Foundation, and The Parkinson's Foundation. This collaboration underscores the importance of the research and the potential impact of bezisterim on Parkinson's disease treatment.
People with newly diagnosed Parkinson's disease who have not been prescribed levodopa or other dopamine receptor agonists may qualify for the trial. Interested individuals can visit www.sunrisePD.com to learn more about participation criteria.
Broader Therapeutic Potential
Beyond Parkinson's disease, BioVie is investigating bezisterim for other neurological and neurodegenerative disorders. The company has completed a Phase 3 study evaluating the drug in patients with mild-to-moderate Alzheimer's disease and is exploring its potential in long COVID, where it may reduce neurological symptoms including fatigue and cognitive dysfunction.
The company believes that bezisterim's dual mechanism of reducing inflammation and improving insulin sensitivity could address fundamental processes involved in multiple neurodegenerative conditions, potentially offering a new paradigm for treatment beyond traditional symptomatic approaches.
If successful, the SUNRISE-PD trial could provide valuable insights into how targeting inflammation and insulin resistance might impact early Parkinson's disease progression, potentially leading to new treatment options for patients at a stage when intervention might be most beneficial.
