Annovis to add European clinical trial sites for Phase 3 study of buntanetap

Annovis Bio announced approval for additional European clinical trial sites for the ongoing Phase 3 study of buntanetap for the treatment of Parkinson’s disease, or PD. Annovis is actively recruiting for the ongoing Phase 3 study with 50 clinical trial sites open and currently enrolling in the US. The approval adds an additional 48 sites in five European Union, or EU, countries, including Italy, Spain, Hungary, Poland and Germany, for the Company’s Phase 3 study of buntanetap for the treatment of Early PD. The locations will enroll the initial cohort of early PD patients. Based on the current enrollment, the Company anticipates having a sufficient number of patients who have received two months of therapy to conduct an interim analysis in the Q2. The interim analysis will be used to determine if the Company’s original estimates for patient enrollment in the Phase 3 trial 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 10mg buntanetap, 20mg buntanetap or placebo, on top of their standard of care, for six months.