Buntanetap for Neurodegenerative Diseases: Positive Recommendation From Data and Safety Monitoring Board

An independent Data and Safety Monitoring Board (DSMB) today issued a positive recommendation regarding the safety of Annovis Bio’s buntanetap—an investigational oral therapy for neurodegenerative diseases such as Alzheimer disease (AD) and Parkinson disease (PD)—at 6 months. This supports the continuation of the ongoing buntanetap pivotal phase 3 AD clinical trial (NCT06709014) without any modification.¹

“We are pleased to receive this positive recommendation from the DSMB,” said Maria Maccecchini, PhD, the president and chief executive officer of Annovis. “This response reinforces our confidence in the safety profile of buntanetap and allows the clinical program 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.”¹

The pivotal phase 3 AD clinical trial of buntanetap is currently recruiting participants across the United States and is now 40% complete. Investigators seek to enroll 760 individuals with early AD (MMSE 21-28), aged 55 to 85, who will be randomly assigned to daily buntanetap 30 mg or a placebo for 1.5 years. The study seeks to evaluate buntanetap’s effects on cognitive function and functional abilities in daily life. Treatment will last for 18 months and will consist of 2 parts: (1) a 6-month assessment of symptomatic effects, followed by (2) an additional 12-month evaluation of buntanetap’s disease-modifying effects.²

“Our previous trials have delivered compelling results, and we have meticulously designed a comprehensive protocol to evaluate both the symptomatic and potential disease-modifying effects of our drug candidate,” said Maccecchini.²

The DSMB is responsible for periodically reviewing accumulated safety data, providing independent recommendations on the conduct, and monitoring the progression of the study. During the open session of the review, Annovis presented an overview of the trial status, including enrollment progress, adverse events, and study timelines. In the closed session, attended only by DSMB voting members to guarantee objectivity and by an unblinded reporting statistician, unmasked safety data were reviewed. Following a comprehensive evaluation, members of the DSMB concluded that no safety concerns were identified and recommended that the clinical trial continue as planned, with no changes necessary. Additionally, the 6-month safety data in patients with AD were consistent with those observed in patients with PD at the same time point. Further safety evaluations are planned at 12 and 18 months.

The first symptomatic efficacy readout is anticipated in early 2027, followed by a disease-modifying readout expected in early 2028.

References

1. Annovis secures DSMB approval to advance pivotal phase 3 trial of buntanetap in Alzheimer’s disease. News release. February 12, 2026. Accessed February 12, 2026. https://www.globenewswire.com/news-release/2026/02/12/3237130/0/en/Annovis-Secures-DSMB-Approval-to-Advance-Pivotal-Phase-3-Trial-of-Buntanetap-in-Alzheimer-s-Disease.html

2. Annovis announces first patients entered into pivotal phase 3 study of buntanetap for early Alzheimer’s disease. News release. February 5, 2025. Accessed February 12, 2026. https://annoviss-bio-staging.webflow.io/press-release/annovis-announces-first-patients-entered-into-pivotal-phase-3-study-of-buntanetap-for-early-alzheimers-disease