Annovis Bio Announces Positive FDA Notice For Buntanetap Phase 3 Clinical Trial In Parkinson’s Disease

FDA indicates the Company may proceed with the Phase 3 clinical study of buntanetap for the treatment of Parkinson’s disease

Excerpt from the Press Release:

BERWYN, Pa., July 7, 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 Company received notice from the FDA that the Phase 3 clinical study in early Parkinson’s patients may proceed. The FDA accepted the final protocol and the clinical development plan, approved the use of the Company’s new large-scale batch of good manufacturing practice material, and found the chronic toxicology in rats and dogs safe and adequate to support long-term human studies lasting decades compared to the previous restriction of one month.

Following a successful Type B meeting for the continued development of buntanetap in Parkinson’s disease with the FDA earlier this year, the Company requested consideration from the FDA on amending the accepted development plan, finalizing the protocol for the Phase 3 study, and proceeding with longer duration clinical trials. The Company submitted all the safety data in mice, rats, dogs and over 200 humans, the chemistry, manufacturing, and controls package for the new large-scale batch, and all the data accumulated over the years for the Company’s Alzheimer’s disease program that also pertained to Parkinson’s disease program.

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