All 84 clinical sites across the U.S. are fully activated, enrolling, and treating patients
The first group of participants reached the 6-month treatment milestone
The study is now 25% complete, keeping Annovis on track for data readout
MALVERN, Pa., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced that all 84 sites for its pivotal Phase 3 study in early AD are now fully activated and enrolling participants, with the majority already treating patients across the U.S. This milestone is complemented by another achievement: the first group of patients has completed the 6-month treatment period, keeping the Company on track to deliver symptomatic data in the second half of 2026.
“Our Phase 3 trial is now 25% complete, with all sites open, and our earliest enrollees having reached the 6-month treatment milestone," said Maria Maccecchini, Ph.D., President and CEO of Annovis. “These achievements keep us on schedule for our first 6-month readout in 2026 and underscore the continued momentum toward bringing buntanetap to patients who urgently need a safe and effective treatment.”
The pivotal Phase 3 study (NCT06709014) aims to enroll a total of 760 patients with early AD and biomarker-confirmed amyloid pathology. The trial employs a dual design: a 6-month readout evaluating the symptomatic efficacy of buntanetap, Annovis' lead drug candidate, followed by an 18-month readout focused on a potential disease-modifying response. Participants who have completed the initial 6-month period seamlessly continue blinded treatment for additional 12 months toward the study completion.
"The pace of enrollment and patient progression through the protocol demonstrates strong execution across all aspects of this pivotal trial," said Melissa Gaines, Senior Vice President of Clinical Operations at Annovis. "This momentum reflects the dedication of our entire team, the excellence of our site partners, and the remarkable engagement of patients and caregivers who recognize the potential impact of our treatment."
More information about the clinical trial and site locations can be found on our website or at ClinicalTrials.gov.
About Annovis
Headquartered in Malvern, Pennsylvania, Annovis is dedicated to addressing neurodegeneration in diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD). The Company is committed to developing innovative therapies that improve patient outcomes and quality of life. For more information, visit www.annovisbio.com and follow us on LinkedIn, YouTube, and X.
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Forward-Looking Statements
This press release contains forward-looking statements under the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended. Actual results may differ due to various risks and uncertainties, including those outlined in the Company’s SEC filings under “Risk Factors” in its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update forward-looking statements except as required by law.
Contact Information:
Annovis Bio Inc.
101 Lindenwood Drive
Suite 225
Malvern, PA 19355
www.annovisbio.com
Investor Contact:
Alexander Morin, Ph.D.
Director, Strategic Communications
Annovis Bio
ir@annovisbio.com
