FDA Gives Green Signal To Annovis Bio's Parkinson's Trial With Buntanetap

  • Annovis Bio Inc ANVS received notice from the FDA that the Phase 3 clinical study with buntanetap in early Parkinson's patients may proceed. 
  • The FDA accepted the final protocol and the clinical development plan and approved using the company's new large-scale batch of good manufacturing practice material.
  • The agency 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.
  • Related: FDA Guides Annovis Bio For Two Phase 3 Buntanetap Trial In Parkinson's Disease.
  • 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 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 its Alzheimer's disease program that also pertained to Parkinson's disease program.
  • Price Action: ANVS shares are up 7.09% at $14.20 during the market session on the last check Thursday.
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