FDA Authorizes Phase 2/3 Trial Procession for Buntanetap in Alzheimer Disease

The Food and Drug Administration (FDA) has authorized the phase 2/3 clinical study of buntanetap (ANVS401; Annovis, Berwyn, PA) in individuals with moderate Alzheimer disease (AD).

Approval to further pursue the development of buntanetap in AD was requested after the submission of the phase 2a study (NCT04524351) , in which participants with early AD treated with 5 to 80 mg/day oral buntanetap for 25±2 days had no adverse events. These results are consistent with the ascending dose study in which side effects did not occur at doses less than 160 mg/day (nausea and vomiting in 36% of participants). Signs of clinical efficacy were also seen with an approximate 30% improvement on the Alzheimer Dementia Assessment Scale-Cognition (ADAS-Cog) scale although the study was not powered for statistical evaluation of this finding.  

"We are very pleased with the clinical progress of buntanetap," said Maria L. Maccecchini, PhD, founder, president, and chief executive officer of Annovis Bio. "In a phase 2a clinical trial in AD and PD, treatment with buntanetap resulted in statistically significant improvement in motor function in PD patients and cognition in AD patients. With this promising data, we have progressed buntanetap into a phase 3 trial for the treatment of early PD, and now with FDA authorization, into a phase 2/3 trial for the treatment of moderate AD. We are on a clinical development pathway to bring forward a promising treatment for both far reaching neurodegenerative indications."

Buntanetap, previously known as posiphen, is a novel drug with a unique mechanism of action targeting multiple proteins implicated in neurodegenerative diseases, including amyloid β, tau, α-synuclein, and TDP43.