Annovis Bio, Inc. is a clinical-stage biopharmaceutical company focused on pioneering treatments for neurodegenerative disorders. The firm's flagship drug, Buntanetap, an oral medication, has successfully advanced through Phase 2a clinical trials for Alzheimer's and Parkinson's diseases. This compound is also currently being evaluated in clinical studies for Alzheimer's disease in individuals with Down Syndrome, as well as for various other chronic neurodegenerative conditions. Beyond Buntanetap, Annovis Bio is developing ANVS405 to offer protection against traumatic brain injury and stroke. Additionally, ANVS301 is progressing through Phase I clinical trials, aiming to enhance cognitive capabilities in the later stages of Alzheimer's disease and broader dementia. The company was founded in 2008 and operates out of Berwyn, Pennsylvania.
Annovis Announces Partnership with Weave Bio, AI Regulatory Platform, in Preparation of NDA for Buntanetap in Alzheimer’s Disease
Annovis Bio announced a collaboration with Weave Bio, an AI regulatory platform, to draft and manage documents for the planned NDA submission of buntanetap in Alzheimer's disease.
The move prepares most of the NDA ahead of the 6-month top-line readout from the pivotal Phase 3 AD trial, which completed enrollment of 862 biomarker-confirmed patients, exceeding the 760 target.
Database lock is targeted for December 2026 with top-line symptomatic data expected in March 2027; the collaboration carries no disclosed financial terms and does not change the regulatory review itself.