Annovis Hits 85% AD Trial Enrollment, 40% PD Extension; NDA Filings Set
ANVS•Annovis enrolled 85% of patients in its pivotal Phase 3 Alzheimer’s trial and 40% in its Parkinson’s extension study, aiming for full enrollment by summer 2026 and Q4 2026, with NDA submissions forecast for early 2027 and early 2028. Cash was $14.2M as of March 31, after a $10M offering.
1. Phase 3 Alzheimer’s Trial Enrollment
Annovis has enrolled 85% of participants in its pivotal Phase 3 Alzheimer’s trial and closed new screening on May 15, 2026 after reaching its target. The Data and Safety Monitoring Board issued a positive safety recommendation at six months, supporting seamless continuation of the trial designed to assess symptomatic effects at six months and disease-modifying effects at 18 months in pTau217-positive early AD patients.
2. Parkinson’s Disease Extension Study Progress
Enrollment in the Parkinson’s open-label extension study has reached 40%, with full enrollment expected in Q4 2026. The study incorporates a skin biopsy biomarker measuring phosphorylated alpha-synuclein and a partnership with NeuroRPM to deploy an AI-powered digital motor function assessment over a 36-month safety and efficacy evaluation.
3. Financial Position and Corporate Updates
As of March 31, 2026, cash and equivalents totaled $14.2M following a $10M registered direct offering in April. R&D expenses rose to $16.7M in Q1 from $5.0M a year earlier. Annovis holds a U.S. patent for buntanetap in neurological injury prevention and plans to submit an NDA for symptomatic AD treatment in early 2027 and for disease-modifying approval in early 2028.
