GlobeNewswire·Aug 6, 2026, 7:30 AM ET

BioVie Announces Topline Results of Phase 2 SUNRISE-PD Trial of Bezisterim in Early Parkinson’s Disease

BIVI

BioVie Inc. announced positive topline results from the Phase 2 SUNRISE-PD trial for its drug candidate bezisterim in early-stage Parkinson's disease patients not previously treated with carbidopa/levodopa.
Patients treated with bezisterim showed statistically significant improvements in motor & non-motor symptoms assessed by MDS-UPDRS Parts I, II, & III compared to placebo.
The trial met prespecified endpoints, demonstrating improved blood-based inflammatory markers & broader biological markers associated with cellular health & nerve cell damage.
A composite endpoint (EPNIC-15) comprising 15 clinically relevant measures showed significant improvement for the bezisterim group (-0.04) versus a worsening trend for the placebo group (+0.18).
Bezisterim reduced plasma biomarkers of neurodegeneration & systemic-inflammation, with 283 of 380 proteins shifting in a direction suggesting slowed disease progression.
Treatment effects were most pronounced in patients with higher baseline inflammation, specifically those with platelet counts >230 x10³/µL, who represent approximately half the trial population.
The study involved 57 participants randomized 1:1 over a 12-week treatment period & demonstrated a safety profile comparable to placebo with no severe or serious adverse events.
Exploratory biomarker data indicated reductions in neuroinflammatory markers (CCL2, CHI3L1, VGF) & a decrease in composite neuronal injury signals such as NfL.
BioVie plans to host a conference call on August 12, 2026, at 4:15 p.m. EDT to discuss the findings & inform the design of a potential pivotal Phase 3 trial.
These results support the hypothesis that targeting neuroinflammation & insulin sensitivity may address significant unmet clinical needs in Parkinson's disease beyond symptomatic treatment.