MALVERN, PA — Annovis Bio Inc. (NYSE: ANVS) expects top-line data and regulatory submissions in 2027 from its fully enrolled pivotal Phase 3 Alzheimer’s disease trial, putting its lead drug candidate buntanetap on a defined path toward a potentially consequential clinical and regulatory test.
The Malvern-based biotechnology company plans to detail the program, along with its Parkinson’s disease work and other upcoming milestones, during a corporate update webinar Wednesday, Sept. 2, at 4 p.m. EDT.
Annovis is developing buntanetap, formerly known as posiphen, as an investigational once-daily oral treatment for neurodegenerative diseases. The company says the drug is designed to inhibit production of multiple neurotoxic proteins associated with Alzheimer’s and Parkinson’s diseases.
With enrollment in the pivotal Alzheimer’s trial complete, Annovis is preparing for the 2027 top-line readout and subsequent regulatory submissions, founder, president and Chief Executive Officer Maria Maccecchini said.
The company also intends to extend its Alzheimer’s program into an open-label study designed to collect longer-term safety data. The first patients are expected to enter that study in October.
“Several key milestones have been reached: our pivotal Phase 3 AD trial is fully enrolled, and preparations are already underway for the top-line data readout and regulatory submissions, both expected in 2027,” Maccecchini said.
Annovis is simultaneously conducting an open-label Parkinson’s disease study. The company is discussing plans with outside experts and the U.S. Food and Drug Administration for a Parkinson’s disease dementia program, according to Maccecchini.
Buntanetap targets the translation of proteins including amyloid precursor protein and amyloid beta, tau, alpha-synuclein and TDP-43 through an RNA-targeting mechanism. The drug remains investigational.
Maccecchini will present the Sept. 2 update and participate in a live question-and-answer session afterward.
Registration for the webinar is available at https://zoom.us/webinar/register/WN_QRF6xO03S9GwsDvpfsxsog.
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.