Annovis Bio Shares Rise 8% After FDA Allows Buntanetap Trial to Proceed
07 Juli 2022 - 04:36PM
Dow Jones News
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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