Annovis Bio announced that every one of its 84 U.S. sites for the pivotal Phase 3 early‑stage Alzheimer’s disease trial is now fully activated, enrolling, and treating patients. The first cohort of participants has already reached the 6‑month treatment milestone, and the study is 25 % complete, putting the company on track for its planned 6‑month symptomatic data readout in the second half of 2026.
The trial’s dual design—an interim 6‑month readout to evaluate symptomatic efficacy and a subsequent 18‑month assessment for disease‑modifying effects—means that a positive 6‑month result could support a future New Drug Application. By reaching the 6‑month milestone, Annovis demonstrates that its execution pipeline is operating as intended, reducing the risk of schedule delays that could otherwise push the NDA filing further into the future.
CEO Maria Maccecchini highlighted the speed of site activation and enrollment, noting that “our Phase 3 trial is now 25 % complete, with all sites open, and our earliest enrollees having reached the 6‑month treatment milestone.” Senior Vice President of Clinical Operations Melissa Gaines added that the team’s dedication and partnership with site investigators were key to maintaining the aggressive timeline. The company’s FDA‑accepted revised protocol, approved in January 2025, underpins the trial’s regulatory strategy and gives the company confidence that the data will meet regulatory expectations.
From a business perspective, the milestone strengthens Annovis’s liquidity position—its current ratio stands at 7.65—and confirms that the company can continue to fund the remaining 75 % of the trial without additional capital raises. The progress also positions Annovis ahead of competitors in the Alzheimer’s space, as its multi‑target approach to neurotoxic proteins differentiates buntanetap from recently approved symptomatic therapies. A successful 6‑month readout would accelerate the company’s path to market and could unlock significant commercial upside once the drug reaches patients.
Investors reacted positively to the announcement, with market sentiment reflecting confidence in the trial’s execution and the potential for a timely NDA filing. Analysts noted that while valuation concerns remain, the operational achievement and the company’s strong cash position are viewed as mitigating factors that support a favorable outlook for Annovis’s future development milestones.
The next key milestone will be the 18‑month disease‑modifying assessment, scheduled for the end of 2027. Annovis will continue to enroll patients to reach its target of 760 participants, and the company will provide further updates as additional data become available.
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