Malvern-based Annovis Bio, a biotechnology company, and California-based Weave Bio, an AI platform for regulatory content and knowledge management, recently entered into a collaboration to support Annovis’ planned new drug application (NDA) for buntanetap.
Annovis is nearing a six-month top-line data readout from the pivotal Phase 3 AD trial for buntanetap, an investigational once-daily oral therapy that inhibits the translation of multiple neurotoxic proteins. The data that will be used during its NDA submission, and the company will
use Weave for drafting, reviewing and managing documents.
“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 regulatory operations senior vice president, said. “Weave will let our regulatory team spend time on scientific judgment and strategy while providing essential assistance on assembling documents in a faster and more organized way. That is a meaningful advantage as we prepare a submission for an investigational therapy we believe has the potential to help millions of patients still waiting for a treatment that can change their lives.”
Annovis expects the database lock for the six-month treatment period to begin in December and be followed by a top-line symptomatic data announcement in March.