ANVS - Annovis Bio Receives FDA Approval to Transition to New Crystal Form of Buntanetap | Benzinga
MALVERN, Pa., July 16, 2024 (GLOBE NEWSWIRE) -- via IBN – Annovis Bio Inc. (NYSE:ANVS) ("Annovis" or the "Company"), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative disorders such as Alzheimer's Disease (AD) and Parkinson's Disease (PD), announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to transition to a new solid form of buntanetap in future clinical trials.
In June 2024, Annovis announced the filing of a composition of matter patent for the new crystal form of buntanetap and a provisional patent for the manufacturing process of this new form. The Company conducted comprehensive bridge studies in various solvents and in animals, comparing the old semi-crystalline form with the new crystalline form of buntanetap. Additionally, Annovis developed an innovative large-scale manufacturing process for the new form. This comprehensive data was submitted to the FDA for review.
The FDA has now approved the continuation of buntanetap's development using the new crystal form. This positive response allows Annovis to conduct a comparative study between the ...