BERWYN, PA — Annovis Bio, Inc. (NYSE: ANVS) has recently announced the completion of the last patient visit in its phase III study of buntanetap, a leading candidate for treating early Parkinson’s disease (PD). The company expects to release topline data from the study in January 2024.
This pivotal trial was a randomized, double-blind, placebo-controlled study designed to assess the efficacy, safety, and tolerability of buntanetap in patients with early-stage PD. Patients received either a 10 mg or 20 mg dose of buntanetap or a placebo for six months, along with their standard care.
The study began in August 2022 and reached full enrollment at an unprecedented rate within just nine months. The trial encompassed 67 sites across the United States and European Union, with a total of 616 screened patients, 523 randomized patients, and 471 completed patients. The rates of screen failure and patient dropouts were lower than projected, at 15% and 9.9% respectively.
Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis, expressed her satisfaction with the progress of the study, stating, “We are pleased to share the completion of our Parkinson’s study which marks a significant step forward in our ongoing mission to bring new therapies for those affected by this challenging neurodegenerative disease.” She added that the study saw a substantial level of participation, with patients enrolling at a record pace.
Melissa Gaines, Senior Vice President of Clinical Operations, thanked all participants and collaborators for their contributions to the efficient and timely completion of the study. She added, “Our team now shifts its focus to diligently cleaning and analyzing the data to meet our goal of sharing the topline results early next year.”
The completion of this study represents a significant milestone for Annovis Bio in its mission to develop innovative treatments for neurodegenerative diseases. The upcoming topline data could potentially herald a new era in the treatment of early-stage Parkinson’s disease, offering hope to millions of patients worldwide.
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