Annovis Bio announced that an independent Data and Safety Monitoring Board (DSMB) has issued a positive recommendation regarding the safety of buntanetap at six months, supporting the continuation of the ongoing pivotal phase-III AD clinical trial without modification.

The DSMB is responsible for periodically reviewing accumulated safety data and providing independent recommendations on the conduct and progression of the study. During the open session, Annovis presented an overview of the trial status, including enrollment progress, adverse events and study timelines. In the closed session, attended exclusively by DSMB voting members to ensure full objectivity and by an unblinded reporting statistician, unmasked safety data were reviewed.

Following a comprehensive evaluation, the DSMB concluded that no safety concerns were identified and recommended that the clinical trial continue as planned, without changes. Moreover, the six-month safety data in Alzheimer’s patients were consistent with those observed in Parkinson’s patients at the same time point. Subsequent safety evaluations are planned at 12 and 18 months.

“We are pleased to receive this positive recommendation from the DSMB. This response reinforces our confidence in the safety profile of buntanetap and allows the clinical programme to proceed without interruption. Importantly, due to the alignment of safety outcomes across the Alzheimer’s and Parkinson’s studies, the FDA indicated it may consider accepting combined safety data in a future NDA submission,” said Maria Maccecchini, PhD, President and CEO, Annovis.

The pivotal phase-III AD clinical trial of buntanetap (NCT06709014) is currently recruiting patients across the United States (US), and is now 40 percent complete. The first symptomatic efficacy readout is anticipated in early 2027, followed by a disease-modifying readout expected in early 2028.