BioVie shares Phase 2 bezisterim data for Parkinson's disease

BioVie Inc. (NASDAQ: BIVI) presented results from its Phase 2 SUNRISE-PD clinical trial evaluating bezisterim in early Parkinson's disease patients at the 151st Annual Meeting of the American Neurological Association, held October 17–20, 2026, in San Diego. The study's abstract was published in Annals of Neurology.

The 57-patient randomized, double-blind, placebo-controlled trial administered bezisterim or placebo for 12 weeks. Patients with above-median platelet counts at baseline — above 230 × 10⁹/L, used as a marker of elevated systemic inflammation — showed statistically significant improvements compared to placebo. In this prespecified subgroup, bezisterim-treated patients showed improvement in MDS-UPDRS Part I non-motor scores (-1.62 vs. +1.86 for placebo; p=0.0124), Part III motor scores (-1.32 vs. +1.26; p=0.0265), and Total Scores (-1.23 vs. +1.21; p=0.0006).

In the overall modified intent-to-treat population, the Composite Benefit Score showed a large treatment effect favoring bezisterim (Cohen's d = -1.61; p=0.0004). Patients receiving bezisterim were 6.25 times more likely to achieve clinically meaningful improvement on the CBS than those receiving placebo (25% vs. 4%). The risk of clinically meaningful worsening was approximately 70% lower with bezisterim than with placebo (14% vs. 46%).

Treatment-emergent adverse events occurred in 39.3% of bezisterim-treated participants and 51.7% of placebo-treated participants. No severe or serious adverse events were reported in either group.

"These results provide evidence that an anti-inflammatory treatment can benefit both motor and, importantly, non-motor symptoms of Parkinson's disease," said Clarence Ahlem, BioVie's Senior Vice President and Program Lead for Parkinson's Disease.

Bezisterim is an investigational oral drug that the company says crosses the blood-brain barrier and targets pathways involved in neuroinflammation. BioVie stated the findings are intended to inform the design of a potential Phase 3 trial.

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