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BioVie Announces Completion of Phase 2 SUNRISE-PD Trial in Early-Stage Parkinson's Disease

BIVI
  • BioVie Inc. completed the final patient evaluation visit for its SUNRISE-PD Phase 2 trial of bezisterim in early-stage Parkinson's disease.
  • The company plans to unblind data & announce topline results in Q3 2026.
  • The SUNRISE-PD trial was a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study involving 57 patients randomized 1:1 to receive 20 mg of bezisterim or placebo twice daily.
  • The study utilized a hybrid decentralized design over 20 weeks, allowing participants to enroll from home or clinical sites to reduce barriers like limited mobility & geographic constraints.
  • Assessments included motor & non-motor endpoints such as UPDRS Parts I-III, PDQ, PDSS, CGI-I/S, & plasma biomarkers of inflammation & neurodegeneration.
  • BioVie recently hosted a virtual KOL event featuring Dr. Suzanne de la Monte to discuss insulin resistance as a driver of Parkinson's & bezisterim's mechanism of action.
  • Dr. de la Monte highlighted the need to address non-motor symptoms including sleep disorders, anxiety, depression, & cognitive slowness.
  • Bezisterim is an investigational oral drug that crosses the blood-brain barrier to reduce inflammation & improve insulin sensitivity without suppressing the immune system.
  • Previous Phase 2 data showed patients with moderate-to-severe Parkinson's taking bezisterim with levodopa had better motor control & fewer morning symptoms.
  • The ADDRESS-LC trial for Long COVID is enrolling ~200 patients, with topline data expected in late summer 2026.
  • BioVie is also advancing BIV201, a terlipressin infusion for advanced liver cirrhosis, which has received FDA Orphan & Fast Track designations.
  • The company's lead candidate bezisterim is also being evaluated in Phase 2 & Phase 3 trials for Alzheimer's disease.