Bezisterim (NE3107) - (SUNRISE-PD)

May 18, 2026: BioVie Inc. (NASDAQ: BIVI) announced completion of the last patient evaluation visit in SUNRISE-PD, its Phase 2b randomized, double-blind, placebo-controlled trial of bezisterim (NE3107) in early-stage Parkinson’s disease patients not treated with carbidopa/levodopa. The company said it is beginning study closeout and plans to announce topline results in calendar Q3 2026; the trial is intended to inform the design of Phase 3 registrational studies.

SUNRISE-PD enrolled ~57 patients randomized 1:1 to bezisterim 20 mg or placebo twice daily during a 12-week double-blind period (20-week hybrid decentralized study overall). Endpoints included motor and non-motor assessments (MDS-UPDRS Parts I-III, PDQ, PDSS, CGI-I/CGI-S) plus plasma biomarkers of inflammation/neurodegeneration (including DNA methylation).

Other upcoming catalyst: the ADDRESS-LC trial in Long COVID is enrolling ~200 patients; topline data are expected in late summer 2026.

BioVie also noted plans to study BIV201 (continuous infusion terlipressin; FDA Orphan and Fast Track designations) in a Phase 3 trial in cirrhosis and ascites to reduce further decompensation.