Phase 2 Trial into Potential Oral Alzheimer’s Treatment Safe to Continue, Independent Board Says

A Phase 2 clinical trial testing Annovis Bio’s oral therapy ANV401 (also known as Posiphen) in people with early Alzheimer’s disease can continue without changes, according to a positive review by the study’s independent Data Safety Monitoring Board (DSMB). The DSMB reviewed safety data, enrollment, participant status, demographic data, and vital signs of the 11 patients currently enrolled in the trial. No side effects have been identified to date. The study, which is still enrolling at its six U.S. sites, is expected to conclude in the spring of 2021. Interim trial results are likely by the end of this year. “We are extremely pleased that the Data Safety Monitoring Board has unanimously supported that the study continues without modification. This trial will provide proof of mechanism and proof of concept for ANVS401,” Maria Maccecchini, PhD, Annovis Bio (previously QR Pharma) CEO, said in a press release. “It will also provide the necessary dose range and safety information we need to progress our drug development into pivotal phase II/III clinical efficacy studies,” Maccecchini added.

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