BERWYN, PA — Chester County-based biopharmaceutical company Annovis Bio, Inc. (NYSE: ANVS) announced this week that its phase II/III study of buntanetap, a potential treatment for Alzheimer’s Disease (AD), has successfully exceeded full enrollment. The announcement comes less than a year since the initiation of the study in March 2023.
Over 700 patients were screened for the study, resulting in a total of 353 enrollees across 54 sites in the United States. The randomized, double-blind, placebo-controlled trial aims to investigate the efficacy, safety, and tolerability of buntanetap in patients with mild to moderate AD over a 12-week period.
Unlike other AD drugs, buntanetap stands out due to its unique mechanism of action, favorable toxicology profile, and oral mode of administration. While most drugs aim to remove a single neurotoxic protein, buntanetap targets multiple neurotoxic proteins – Amyloid Beta, Tau, alpha Synuclein, and TDP43. This multi-pronged approach is designed to improve synaptic transmission and axonal transport, reduce inflammation, and potentially reverse the destructive effects of Alzheimer’s on cognitive function.
In October 2023, Annovis announced positive efficacy interim analysis and subsequent safety review of buntanetap by the Data and Safety Monitoring Board (DSMB). The DSMB recommended that Annovis continue the trial as originally designed, with data expected to be released by the end of March 2024.
Annovis’ founder, president, and CEO, Maria Maccecchini, Ph.D., expressed her satisfaction with the study’s progress. She said, “We are very pleased to share the news of the successful completion of enrollment for our phase II/III study of buntanetap in Alzheimer’s Disease. The number of enrolled patients exceeded our initial projections, revealing the Alzheimer’s community’s strong endorsement of our mission to develop a treatment targeting multiple neurotoxic proteins.”
This successful enrollment signifies a significant milestone for Annovis Bio and its commitment to advancing Alzheimer’s disease treatment. If successful, buntanetap could potentially transform the therapeutic landscape for this debilitating condition, offering hope to millions of patients worldwide.
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