Annovis Bio Partners with Weave Bio for NDA Preparation for Buntanetap
News related to:Annovis Bio · 1 min read
MALVERN, Pa., Sept. 23, 2026 /CourierPR/ -- Annovis Bio, a Phase 3 clinical-stage biotechnology company, has announced a strategic partnership with Weave Bio, an artificial intelligence (AI) regulatory platform, to support the preparation of the New Drug Application (NDA) for buntanetap, an investigational oral therapy for Alzheimer’s disease (AD) and Parkinson’s disease (PD).
Under the collaboration, Annovis will leverage Weave Bio’s AI platform to draft, review, and manage the NDA documents. The primary goal is to have most of the NDA ready before the 6-month top-line data readout from the pivotal Phase 3 AD trial, which is expected to form the basis of the submission. The regulatory and clinical teams at Annovis will retain full responsibility for content, verification, and final approval of every document submitted to the U.S. Food and Drug Administration (FDA).
The Phase 3 AD study (NCT06709014) has successfully enrolled 862 biomarker-confirmed patients, surpassing the original target of 760. The Company aims to reach the database lock for the 6-month treatment period in December 2026, followed by the top-line symptomatic data announcement in March 2027.
Buntanetap, formerly known as posiphen, is an investigational once-daily oral therapy that inhibits the translation of multiple neurotoxic proteins, including amyloid beta, tau, alpha-synuclein, and TDP-43, through a specific RNA-targeting mechanism of action. By addressing the underlying causes of neurodegeneration, Annovis aims to halt disease progression and improve cognitive and motor functions in patients.
The collaboration follows the completion of enrollment in Annovis’ pivotal Phase 3 AD study, which has exceeded the original target of 760 patients. The Company aims to file the NDA based on the top-line results, which are expected to provide a comprehensive view of the therapy’s efficacy and safety.
Annovis and Weave Bio have aligned their approach around the FDA’s guidance on the use of AI to support regulatory decision-making, issued in January 2025. This guidance ensures that regulatory professionals maintain control over AI-assisted drafting, extraction, traceability, and review processes.