BioVie Advances Parkinson’s Research with SUNRISE-PD Study Completion

BioVie Inc., a clinical-stage company developing therapies for neurological and neurodegenerative diseases, announced completion of the last patient evaluation visit in its SUNRISE-PD Phase 2 trial of bezisterim in early-stage Parkinson’s disease. With the final treatment visit done, the company will begin study closeout and expects to report topline results in Q3, after unblinding later this year. The trial is designed to evaluate bezisterim’s impact on motor and non-motor endpoints and inform Phase 3 registrational trial design. A recent virtual KOL event highlighted insulin resistance in neurodegenerative disease pathology and bezisterim’s mechanism of action and effects on non-motor symptoms.

According to Precedence Research, the Global Decentralized Clinical Trials in Neurology market was valued at USD 1.48 billion in 2025 and is projected to grow from USD 1.71 billion in 2026 to approximately USD 6.38 billion by 2035, expanding at a CAGR of 15.80% from 2026 to 2035, driven by the rising neurological disorder prevalence.

Innovating Parkinson’s Trials: Decentralized Design and Centralized Scoring

SUNRISE-PD is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled trial in early-stage Parkinson’s disease patients not previously treated with carbidopa/levodopa. Over 20 weeks, including a 12-week double-blind phase, 57 patients received 20 mg bezisterim or placebo twice daily. The hybrid decentralized design enabled home or site participation, with remote supervised motor assessments and centralized Part III scoring. Endpoints included MDS-UPDRS Parts I–III, PDQ, PDSS, CGI-I, and CGI-S. Plasma biomarkers of inflammation, neurodegeneration, and DNA methylation were evaluated to assess biologic changes supporting bezisterim’s metabolic, anti-inflammatory, symptom-modifying, and disease-progression effects.

Bezisterim’s Role in Modulating Inflammation and Enhancing Brain Health

Bezisterim (NE3107) is an investigational oral drug that crosses the blood-brain barrier, reduces inflammation, improves insulin sensitivity, and modulates ERK, NFκB, and TNF-α pathways without suppressing immunity. It is being evaluated for Parkinson’s disease, Long COVID, and Alzheimer’s disease. A Phase 2 Parkinson’s study showed improved motor control with levodopa and few drug-related side effects. The SUNRISE-PD Phase 2 trial is evaluating bezisterim monotherapy in untreated patients. The ADDRESS-LC trial is assessing neurological Long COVID symptoms linked to NFκB-mediated inflammation. Phase 2 and 3 Alzheimer’s studies showed preliminary cognitive and biomarker improvements, supporting further evaluation.

A recent report by Precedence Research highlights that the Decentralized Clinical Trials in Neurology Market is benefiting from the rise of decentralized clinical trials.