CARSON CITY, Nev., August 6, 2026

BioVie Inc. announced positive topline results from its Phase 2 SUNRISE-PD trial, demonstrating that its investigational therapy bezisterim (NE3107) achieved statistically significant improvements over placebo in patients with early-stage Parkinson’s disease. The randomized, double-blind, placebo-controlled study met its predefined objectives by showing meaningful improvements across MDS-UPDRS Parts I, II, and III, covering both motor and non-motor symptoms, alongside favorable changes in blood-based inflammatory biomarkers. Patients treated with bezisterim also achieved superior results on the EPNIC-15 composite endpoint, which integrates 15 clinically relevant Parkinson’s disease measures, providing additional evidence supporting the drug’s potential to address the underlying biology of Parkinson’s disease rather than offering only symptomatic relief.

Broad Biomarker Improvements Support Disease-Modifying Potential

Beyond clinical improvements, bezisterim demonstrated encouraging biological activity by significantly reducing markers of neuroinflammation and systemic inflammation, including CCL2, CHI3L1, IL-6, TNF-α, IFN-γ, and other inflammatory indicators. The treatment also showed a proteome-wide impact, with 283 of 380 analyzed proteins shifting toward profiles associated with slower disease progression, suggesting broad biological target engagement. Exploratory analyses further indicated improvements in neurodegeneration biomarkers such as neurofilament light chain (NfL), GFAP, UCHL1, MAPT, and Aβ42, supporting the possibility that bezisterim may influence mechanisms linked to neuronal preservation. Investigators observed that patients with higher baseline platelet counts, an inflammatory biomarker, experienced even greater clinical benefits, offering a potential strategy for patient selection in future late-stage clinical development.

Favorable Safety Profile and Phase 3 Development Strategy

The SUNRISE-PD trial enrolled 57 treatment-naïve patients with early Parkinson’s disease who received either 20 mg bezisterim twice daily or placebo for 12 weeks. The therapy was well tolerated, with no severe or serious adverse events reported, while overall adverse event rates were comparable or lower than placebo. According to BioVie, these findings establish both proof-of-mechanism and proof-of-concept, providing a strong foundation for designing a potentially pivotal Phase 3 clinical trial. The company plans to present the complete dataset during a conference call on August 12, 2026, while continuing development of bezisterim across additional neurological indications, including Long COVID and Alzheimer’s disease, further expanding its pipeline targeting neuroinflammation.

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BioVie Strengthens Pipeline with Multi-Indication Development Strategy

The encouraging Parkinson’s disease data reinforce BioVie’s strategy of targeting neuroinflammation and insulin resistance as common mechanisms underlying several neurological disorders. In addition to advancing bezisterim for Parkinson’s disease, the company is conducting the ADDRESS-LC trial in Long COVID, with topline data expected later this summer, while also pursuing additional development opportunities in Alzheimer’s disease. Separately, BioVie continues advancing BIV201, a continuous infusion formulation of terlipressin for advanced liver disease, which has received both FDA Orphan Drug and Fast Track designations. Collectively, the positive Phase 2 Parkinson’s results position bezisterim as one of the company’s most promising clinical assets and support further regulatory discussions aimed at advancing the therapy into late-stage clinical development.

Source:BioVie press release