In this episode, Dr. Maccecchini discusses the company’s recent meetings with the U.S. Food and Drug Administration (FDA), which resulted in clearance to initiate pivotal Phase 3 studies of buntanetap in early-stage AD patients.

“To date, we have conducted four small studies in Alzheimer’s, and now the FDA has granted us clearance to do the very last study, which is really a confirmation of the study we just completed,” she explains. “Once we have that confirmation, we’ll be able to submit a request for market approval.”

“We are so excited about this data, because buntanetap is good in both Alzheimer’s and Parkinson’s. The reason that we believe it works in a number of neurodegenerative diseases is that it attacks more than one neurotoxic protein. What pharma has done to date is attack mostly amyloid-beta plaques. If you attack plaques, you get a small response. However, if you attack more than one toxic protein, and in the brain of an Alzheimer’s patient there are at least four toxic proteins, you have a better outcome.”

Join host, Carmel Fisher and Dr. Maria Maccecchini, Founder, President, and CEO of Annovis Bio, to learn more about the company’s strategy to move rapidly toward a potential New Drug Application (NDA) filing following commencement of its upcoming Phase 3 study.

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