Annovis Bio Announces FDA Authorization to Proceed with Phase 2/3 Trial for Buntanetap in Alzheimer’s Disease
Excerpt from the Press Release:
BERWYN, Pa., Oct. 6, 2022 /PRNewswire/ — Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company addressing neurodegenerative diseases, announced today that the U.S. Food and Drug Administration (FDA) has authorized the Phase 2/3 clinical study of buntanetap in moderate Alzheimer’s Disease (AD).
Following the submission of the Phase 2a clinical safety data and the chronic toxicology data in animals, the Company requested approval to further pursue the development of buntanetap in AD. The FDA approved the Company’s development plan, study protocol and authorized the initiation of the Phase 2/3 clinical study of buntanetap in AD.
“We are very pleased with the clinical progress of buntanetap,” said Maria L. Maccecchini, Ph.D., Founder, President, and CEO 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 ANVS401 or Posiphen) is an oral translational inhibitor of neurotoxic aggregating proteins (TINAPs), which mode of action leads to a lower level of neurotoxic proteins and consequently less toxicity in the brain.
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