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Annovis Bio provides enrollment update for ongoing Phase 3 study of buntanetap
The Fly

Annovis Bio provides enrollment update for ongoing Phase 3 study of buntanetap

Annovis Bio provided a patient enrollment update for the Company’s ongoing Phase 3 study of buntanetap for the treatment of Parkinson’s disease, or PD. 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 purpose of the interim analysis is to determine if the Company’s original estimates for patient enrollment in the Phase 3 trial, 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 10mg buntanetap, 20mg buntanetap or placebo, on top of their standard of care, for six months. Movement Disorder Society-Sponsored Revision of the Unified Parkinson’s Disease Rating Scale Part II and III will be used as primary endpoints, while total MDS-UPDRS and Participant Global Impression of Change will be secondary endpoints.

Published first on TheFly

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