BERWYN, PA — Annovis Bio, Inc. (NYSE: ANVS) announced recent approval for additional European clinical trial sites for the ongoing Phase 3 study of buntanetap for the treatment of Parkinson’s disease (“PD”).
Annovis is actively recruiting for the ongoing Phase 3 study with 50 clinical trial sites open and currently enrolling in the United States. The approval adds an additional 48 sites in five European Union (“EU”) countries, including Italy, Spain, Hungary, Poland and Germany, for the Company’s Phase 3 study of buntanetap for the treatment of Early PD.
Maria L. Maccecchini, Ph.D., Founder, President, and CEO of Annovis, commented: “We are pleased to significantly expand our geographic reach with the addition of these EU sites that gives us the ability to efficiently enroll European patients in our study.”
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 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 (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.
The Company’s Phase 3 trial in PD builds upon earlier, proof-of-concept data from a Phase 2a study which demonstrated that patients treated with buntanetap showed statistically significant improvements in both motor function and coding speed, as measured by MDS-UPRDS Part III and WAIS Coding scores.1 Additionally, no clinically significant adverse events were observed in the Phase 2a study, and its pharmacokinetics were found to be in line with levels measured earlier in humans.
1 Fang et al: Buntanetap Proves Promising in Both Alzheimer’s and Parkinson’s Patients; J Prevention Alzheimer Disease 10-2022
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