Annovis Bio Inc. announced on February 5, 2025, that the first two patients have been entered into the pivotal Phase 3 study evaluating buntanetap in early Alzheimer's disease (AD). This marks a significant milestone in advancing buntanetap toward market approval. The study is a randomized, placebo-controlled, double-blind trial designed to assess the safety and efficacy of a daily dose of buntanetap.
The treatment period will last for 18 months, comprising a 6-month assessment of symptomatic effects followed by an additional 12-month evaluation of buntanetap’s potential disease-modifying effects. This Phase 3 protocol received FDA approval following positive data from previous Phase 2/3 trials, which demonstrated significant cognitive improvement in a subgroup of early AD patients and showed no safety concerns.
The company anticipates enrolling over 750 participants across approximately 100 sites in the United States. The initial 6-month portion of the study is funded by the recently completed $21 million public offering, with the 12-month phase expected to be supported by additional capital from warrant exercises. This initiation brings hope for a new Alzheimer's treatment.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.