Annovis announced a collaboration with Weave Bio to use the AI regulatory platform for drafting, reviewing and managing New Drug Application documents as the company prepares an NDA for buntanetap.
Under the arrangement, Annovis’ regulatory and clinical teams will retain full responsibility for content, verification and final approval of every document submitted to the U.S. Food and Drug Administration.
The partnership is intended to accelerate assembly of submission materials so the company can shorten the time from top-line results to filing.
The collaboration follows completion of enrollment in Annovis’ pivotal Phase 3 Alzheimer’s disease study, which enrolled 862 biomarker-confirmed patients, exceeding the original target of 760.
Annovis aims to reach database lock for the six-month treatment period in December 2026, with a top-line symptomatic data announcement planned for March 2027.
Annovis is a Phase 3 clinical-stage biotechnology company developing buntanetap for Alzheimer’s and Parkinson’s diseases; the company claims buntanetap is an investigational once-daily oral therapy that inhibits translation of multiple neurotoxic proteins through an RNA-targeting mechanism, according to the company.
