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Annovis Secures DSMB Approval to Advance Pivotal Phase 3 Trial of Buntanetap in Alzheimer's Disease

ANVS
  • An independent Data and Safety Monitoring Board (DSMB) issued a positive safety recommendation for buntanetap at 6 months.
  • The recommendation supports continuing the pivotal Phase 3 Alzheimer's disease clinical trial without modification.
  • No safety concerns were identified during the comprehensive evaluation of unmasked safety data.
  • Six-month safety data in Alzheimer's patients were consistent with those observed in Parkinson's patients at the same time point.
  • The FDA indicated it may accept combined safety data from Alzheimer's and Parkinson's studies in a future New Drug Application.
  • The Phase 3 trial (NCT06709014) is currently 40% complete across the United States.
  • The first symptomatic efficacy readout is anticipated in early 2027.
  • A disease-modifying readout is expected in early 2028.
  • Subsequent safety evaluations are planned for 12 and 18 months.