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

Core Viewpoint - Annovis Bio, Inc. has received a positive recommendation from an independent Data and Safety Monitoring Board (DSMB) regarding the safety of its investigational oral therapy, buntanetap, for neurodegenerative diseases, allowing the continuation of the Phase 3 clinical trial without modifications [1][3]. Group 1: Clinical Trial Progress - The DSMB reviewed safety data and recommended that the clinical trial continue as planned, with no safety concerns identified [3]. - The pivotal Phase 3 clinical trial for Alzheimer's disease (AD) is currently 40% complete, with patient recruitment ongoing across the United States [4]. - The first symptomatic efficacy readout is expected in early 2027, followed by a disease-modifying readout anticipated in early 2028 [4]. Group 2: Drug Mechanism and Company Overview - Annovis Bio is developing buntanetap, an investigational once-daily oral therapy that targets multiple neurotoxic proteins associated with neurodegenerative diseases [5]. - The company aims to halt disease progression and improve cognitive and motor functions in patients suffering from Alzheimer's disease and Parkinson's disease [5]. Group 3: Future Considerations - The FDA may consider accepting combined safety data from both Alzheimer's and Parkinson's studies for a future New Drug Application (NDA) submission [4].