MALVERN, PA — Annovis Bio Inc. (NYSE: ANVS) has initiated its pivotal Phase 3 clinical trial evaluating buntanetap as a treatment for early Alzheimer’s disease (AD), marking an important step forward in the fight against this devastating condition. The first two patients have been enrolled at trial sites in Winter Park, FL, and Tom’s River, NJ.
The Phase 3 study is a randomized, placebo-controlled, double-blind trial designed to assess the safety and efficacy of buntanetap, a small molecule therapy targeting neurodegeneration. The trial will span 18 months and include two key parts: a 6-month evaluation of symptomatic effects, followed by a 12-month period examining the drug’s potential to modify disease progression. Primary outcomes will be measured using the Alzheimer’s Disease Assessment Scale-Cognitive 13 (ADAS-Cog13) and the Alzheimer’s Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-iADL) scale.
“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,” said Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis Bio. “Our previous trials have delivered compelling results, and we have meticulously designed a comprehensive protocol to evaluate both the symptomatic and potential disease-modifying effects of our drug candidate.”
The trial is expected to enroll over 750 participants across approximately 100 sites in the United States. The study protocol received FDA approval following data from an earlier Phase 2/3 trial, which demonstrated significant cognitive improvement in patients with early AD and raised no safety concerns.
Funding and Commitment
Annovis Bio recently secured $21 million in capital through a public offering, which will fund the initial 6-month phase of the trial. The company anticipates additional funding from warrant exercises to support the subsequent 12-month phase. These efforts reflect Annovis Bio’s commitment to developing breakthrough therapies for Alzheimer’s and related diseases.
“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,” said Melissa Gaines, SVP of Clinical Operations. “We are grateful to the community for their continuous support and to everyone who has contributed to making this trial a reality.”
About Buntanetap
Buntanetap is an orally administered drug designed to address neurodegeneration by blocking the production of neurotoxic proteins. This mechanism improves axonal transport and synaptic transmission, reduces neuroinflammation, and restores brain cell health, offering potential to reverse neurodegeneration and improve quality of life for patients.
Annovis Bio’s latest initiative represents a significant step in Alzheimer’s disease research. With its robust trial design, innovative science, and comprehensive funding strategy, the company is poised to deliver new hope for millions affected by the disease.
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