Annovis Bio, Inc. announced that an independent DSMB issued a positive safety recommendation for buntanetap at 6 months, supporting continuation of the pivotal Phase 3 Alzheimer's disease trial without modification. The trial is 40% complete, with first symptomatic efficacy readout anticipated in early 2027.
Key takeaways
DSMB recommended continuation of Phase 3 AD trial of buntanetap without changes after 6-month safety review
No safety concerns identified; safety data consistent with Parkinson's patients
Pivotal Phase 3 AD trial (NCT06709014) is 40% complete and recruiting in the US
First symptomatic efficacy readout expected in early 2027; disease-modifying readout in early 2028
FDA may consider combined safety data from AD and PD studies for future NDA submission