MALVERN, PA — Annovis Bio, Inc. (NYSE: ANVS) is integrating Weave Bio’s artificial intelligence platform into preparations for a planned buntanetap New Drug Application, aiming to shorten the time between pivotal Alzheimer’s disease trial results expected in March 2027 and a potential filing with the U.S. Food and Drug Administration.
Annovis will use Weave to draft, review, and manage regulatory documents while its clinical and regulatory teams retain responsibility for verifying and approving material submitted to the FDA.
The strategy is intended to allow Annovis to complete much of the NDA before results are available from its pivotal Phase 3 Alzheimer’s disease trial. The company expects to reach database lock for the six-month treatment period in December and report top-line symptomatic data in March 2027.
“Our goal is to have most of the NDA ready before the data readout, so the path from the top-line results to filing is as short as possible,” Eve Damiano, Annovis’ senior vice president of regulatory operations, stated.
The collaboration follows completion of enrollment in the Phase 3 study, identified as NCT06709014. Annovis enrolled 862 biomarker-confirmed patients, exceeding its original target of 760.
Buntanetap is an investigational oral therapy being developed for neurodegenerative diseases including Alzheimer’s and Parkinson’s disease. Annovis is currently in Phase 3 clinical development.
Weave’s platform will assist with drafting, information extraction, document traceability, and review. Annovis and Weave have structured the work to keep regulatory professionals in control of the AI-assisted process.
That approach follows FDA guidance addressing the use of AI to support regulatory decision-making. The agency’s January 2025 draft guidance outlines a risk-based framework for evaluating AI models used to generate information or data supporting decisions about drug safety, effectiveness, or quality.
The collaboration puts the regulatory filing process on a parallel track with Annovis’ late-stage clinical program, allowing document preparation to advance while the company waits for the trial data expected to underpin its planned application.
Support the local news that supports Chester County. MyChesCo delivers reliable, fact-based reporting and essential community resources—free for everyone. If you value that, click here to become a patron today.