MALVERN, PA — Annovis Bio Inc. (NYSE: ANVS) announced that an independent Data and Safety Monitoring Board has recommended continuation of its ongoing Phase 3 clinical trial of buntanetap in Alzheimer’s disease patients following a six-month safety review.
The company said the DSMB found no safety concerns and advised that the pivotal Phase 3 Alzheimer’s disease trial proceed without modification.
According to Annovis, the DSMB reviewed accumulated safety data during both open and closed sessions. In the closed session, unmasked safety data were evaluated by voting members and an unblinded statistician.
The company stated that six-month safety findings in Alzheimer’s patients were consistent with data previously observed in Parkinson’s disease patients at the same time point.
Additional safety evaluations are planned at 12 and 18 months, Annovis said.
Maria Maccecchini, president and chief executive officer of Annovis, said the DSMB recommendation supports continuation of the clinical program. She added that the U.S. Food and Drug Administration has indicated it may consider combined safety data from the Alzheimer’s and Parkinson’s studies in a future new drug application submission.
The Phase 3 Alzheimer’s disease trial, identified as NCT06709014, is recruiting patients across the United States and is approximately 40% enrolled, according to the company.
Annovis said it anticipates a first symptomatic efficacy readout in early 2027, followed by a disease-modifying readout in early 2028.
Annovis Bio is a clinical-stage biotechnology company developing buntanetap, an investigational oral therapy for neurodegenerative diseases including Alzheimer’s and Parkinson’s.
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