Annovis Bio Initiates Pivotal Phase 3 Study for Early Alzheimer’s Disease

On February 5, 2025, Annovis Bio, Inc. (NYSE:ANVS) disclosed that the initial patients had entered its pivotal Phase 3 study for early Alzheimer’s disease. The company, a late-stage clinical drug platform firm focusing on innovative therapies for neurodegenerative conditions like Alzheimer’s and Parkinson’s disease, shared this vital development in a recent press release.

Maria Maccecchini, Ph.D., the Founder, President, and CEO of Annovis, expressed, “The launch of our highly anticipated AD study is a significant milestone in advancing buntanetap toward market approval and addressing the unmet medical need of millions of patients.” She highlighted the company’s earlier successful trials and the thorough protocol designed to assess both symptomatic and potential disease-altering effects of the drug candidate.

The Phase 3 study, a randomized, placebo-controlled, double-blind endeavor, aims to evaluate the safety and effectiveness of buntanetap in early Alzheimer’s patients over 18 months. Following FDA approval rooted in positive data from prior trials, the study will include a 6-month symptomatic effects evaluation, succeeded by a 12-month analysis of potential disease-modifying impacts.

Annovis recently concluded a public offering, securing $21 million from 5,250,000 units comprising one share of common stock and one warrant for each share, to fund the initial 6-month part of the trial. The subsequent 12-month phase is expected to be financed through additional capital from warrant exercises.

Melissa Gaines, SVP of Clinical Operations at Annovis, remarked, “Alzheimer’s steals so much from individuals and their families, but with drugs like buntanetap, we aim to restore quality of life and bring hope to those affected.” Gaines expressed gratitude for community support and the collective effort that led to the realization of the trial. She stressed optimism about reshaping the future of Alzheimer’s treatment.

The pivotal outcomes of the study will focus on cognition and functional ability assessments using standardized scales. Annovis foresees enrolling more than 750 participants across approximately 100 sites in the United States, with initial recruitment taking place at designated sites in Florida and New Jersey.

Buntanetap, the drug under evaluation, targets neurodegeneration by interrupting the translation of harmful proteins, ultimately restoring nerve cell health and brain function. Annovis, headquartered in Malvern, Pennsylvania, is dedicated to combating neurodegenerative diseases like Alzheimer’s and Parkinson’s.

Investors and stakeholders interested in updates are encouraged to register for email alerts on Annovis’ website. The company emphasizes a forward-looking approach while highlighting potential risks detailed in its SEC filings.

That concludes the report on the recent developments at Annovis Bio regarding its pivotal Phase 3 study for early Alzheimer’s disease.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Annovis Bio’s 8K filing here.

Annovis Bio Company Profile

Annovis Bio, Inc, a clinical stage drug platform company, develops drugs to treat neurodegeneration. The company's lead product candidate is Buntanetap, which has completed three Phase 1/2 clinical trials for the treatment of Alzheimer's disease (AD), Parkinson's disease, and other chronic neurodegenerative diseases.