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Annovis Bio Announces Positive FDA Feedback for Buntanetap Phase 3 Clinical Development in Parkinson’s Disease

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Annovis Bio Announces Positive FDA Feedback for Buntanetap Phase 3 Clinical Development in Parkinson's Disease | Pharmtech Focus

Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a clinical-stage drug platform company addressing neurodegenerative diseases, today announced that the company held a successful Type B meeting with the U.S. Food and Drug Administration (FDA) with regard to the Company’s planned Phase 3 clinical studies of Buntanetap for the treatment of Parkinson’s Disease (PD) as an offshoot of the Company’s clinical program in Alzheimer’s Disease (AD).

Following the Company’s submission of the Phase 2 clinical data and the chronic toxicology data in animals, the Company requested directions to further pursue the development of Buntanetap in PD. The FDA provided guidance on the initiation of the Phase 3 clinical studies of Buntanetap for PD in parallel with the AD program. The agency detailed guidance on the specific endpoints, entry criteria, and further study parameters for two Phase 3 studies that would support a broad indication for both early and late PD.

“We appreciate the thoughtful and clear feedback from the FDA regarding our clinical program, and we are thrilled with the acceptance of our proposed development plan for Buntanetap in Parkinson’s Disease,” said Maria L. Maccecchini, Ph.D., Founder, President, and CEO of Annovis Bio. “Now we can continue with all necessary steps to begin the Phase 3 trials in PD.”

Additionally, the FDA provided guidance on updating the existing Investigational New Drug Application (IND) for AD based on the result of the successful Phase 2 study and in preparation for an End of Phase 2 meeting on the AD indication.

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