By Chris Wack

 

Annovis Bio Inc. shares were up 8% to $14.30 after the company said it has received notice from the U.S. Food and Drug Administration that its Phase 3 clinical study of buntanetap in early Parkinson's patients may proceed.

The stock ended Wednesday's session up 7%, but is still down 18% year-to-date.

The company said 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 more than 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.

The company plans to start recruiting for a U.S. clinical trial soon, expected later this summer.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

July 07, 2022 10:21 ET (14:21 GMT)

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