BioVie reports topline Phase 2 SUNRISE-PD results for bezisterim in early Parkinson's disease
The company said its trial met prespecified endpoints, with bezisterim showing statistically significant benefits on inflammatory, motor, and non-motor measures versus placebo.
BioVie Inc. announced on August 6, 2026 topline results from its Phase 2 SUNRISE-PD trial testing bezisterim in patients with early-stage Parkinson's disease. The company said the trial met its prespecified endpoints and achieved its objectives, reporting that bezisterim improved blood-based inflammatory markers along with a broader set of biological markers tied to cellular health and nerve cell damage.1 Patients on bezisterim showed greater improvement than placebo across several clinical measures of daily living, motor symptoms, and non-motor symptoms.1
The trial, registered as NCT06757010, is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study intended to establish proof-of-mechanism and proof-of-concept in early-stage Parkinson's patients who had not yet started dopaminergic therapy with carbidopa/levodopa.1 It used a hybrid decentralized design spanning 20 weeks total, including a 12-week treatment period plus screening and safety follow-up.1 After screening and a clinical stability assessment, 57 participants were split evenly between 20 mg of bezisterim and matching placebo, dosed twice daily for 12 weeks.1
On the composite EPNIC-15 endpoint, most bezisterim-treated patients improved, while placebo patients moved in the opposite direction (bezisterim change of -0.04 versus +0.18 for placebo, Cohen's d = -0.94, p=0.0006).1 Patients with higher baseline inflammation, including those with platelet counts above 230 x10³/µL, roughly half the study population, showed significant advantages over placebo across all clinical measures.1
Bezisterim was reported as well tolerated with a safety profile similar to placebo; adverse events occurred in 39.3% of bezisterim patients versus 51.7% of placebo patients, with no serious adverse events and one treatment-related event in each group.1
BioVie will host a conference call at 4:15 p.m. EDT on August 12, 2026 to discuss the findings.1 The company said secondary and exploratory endpoints are meant to help define bezisterim's profile for designing a potential pivotal Phase 3 trial.1
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