MALVERN, PA — Annovis Bio Inc. (NYSE: ANVS) has announced a successful outcome from its recent End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA). The FDA has given the green light to proceed with pivotal Phase 3 trials for buntanetap, a promising treatment for early Alzheimer’s disease (AD), based on positive Phase 2/3 clinical data demonstrating symptomatic improvement in patients.
The Phase 3 program will include two key studies: a 6-month trial aimed at confirming the symptomatic benefits of buntanetap, and an 18-month trial to explore its potential disease-modifying effects. Annovis Bio plans to conduct both studies, though a well-executed 6-month trial might suffice for a New Drug Application (NDA) submission within a year of starting the trial.
Importantly, the FDA has raised no issues regarding buntanetap’s safety profile, including aspects such as liver enzymes and drug interactions. The approval also extends to the use of a new crystal form of the drug in ongoing development efforts.
Maria Maccecchini, Ph.D., the Founder, President, and CEO of Annovis Bio, expressed enthusiasm about this milestone, stating, “We are now ready to move into the highly anticipated Phase 3 stage. Our priority is to bring the treatment to patients as early as possible, and we are committed to ensuring the next clinical trial is executed at the highest standards to attain an expedited NDA submission.”
Preparations for the initiation of these trials are already underway, with plans to begin early next year. Annovis Bio remains dedicated to advancing this potential treatment for Alzheimer’s disease, aiming to deliver new hope to patients and their families.
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