Annovis Bio (NYSE:ANVS) received approval to open 48 clinical trial sits in five European Union countries for its ongoing Phase 3 study of buntanetap for the treatment of Parkinson’s disease (PD).
The company is actively recruiting for the ongoing Phase 3 study with 50 clinical trial sites open and currently enrolling in the United States. The European sites are in Italy, Spain, Hungary, Poland and Germany.
Based on current enrollment, Annovis anticipates having a sufficient number of patients who have received two months of therapy to conduct an interim analysis in the second quarter of 2023.
The interim analysis will be used to determine if the company’s original estimates for patient enrollment in the Phase 3 trial of 150 patients per arm will be sufficient to observe a statistically significant treatment effect in both scales between the active arms and the control arm of the study after six months of treatment.
The ongoing Phase 3 trial is a randomized, double-blind, placebo-controlled trial investigating the efficacy, safety, and tolerability of buntanetap in patients with early-stage Parkinson’s disease. Patients are being treated with 10 mg buntanetap, 20 mg buntanetap or placebo, on top of their standard of care, for six months.
