MALVERN, PA — Annovis Bio, Inc. (NYSE: ANVS) announced that all 84 clinical sites in its pivotal Phase 3 study for early Alzheimer’s disease (AD) are now fully activated and enrolling patients, marking a major step forward in the company’s late-stage development program. Most sites are already treating participants, and the first group of patients has completed the six-month treatment phase—keeping the company on track to deliver symptomatic data in the second half of 2026.
The trial, now 25% complete, evaluates buntanetap, Annovis’ lead therapeutic candidate designed to improve brain function by targeting multiple neurotoxic proteins involved in neurodegeneration. “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 reflect our commitment to patients seeking a safe and effective treatment.”
The Phase 3 study (NCT06709014) will ultimately include 760 participants with early Alzheimer’s disease confirmed by amyloid biomarkers. It uses a dual design—an initial six-month assessment of buntanetap’s symptomatic benefits followed by an 18-month evaluation for potential disease-modifying effects. Patients who complete the first phase seamlessly transition into the extended treatment period under blinded conditions.
Melissa Gaines, Senior Vice President of Clinical Operations, noted that the pace of progress highlights strong execution and collaboration. “The pace of enrollment and patient progression through the protocol demonstrates strong execution across all aspects of this pivotal trial,” she said. “This momentum reflects the dedication of our entire team, the excellence of our site partners, and the remarkable engagement of patients and caregivers.”
With its trial network fully operational and early milestones achieved, Annovis Bio remains positioned to advance buntanetap as a potential next-generation therapy in the fight against Alzheimer’s disease.
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