(RTTNews) - The U.S. Food and Drug Administration indicated Annovis Bio Inc. (ANVS) may proceed with the phase 3 clinical study of buntanetap for the treatment of Parkinson's disease, the company said in a statement.
In Thursday pre-market trade, ANVS was trading at $14.59 up $1.33 or 10.03 percent.
The company said it will start recruiting for the US clinical trial soon, expected later this summer.
".. The positive FDA review affirms the Company's path to securing approval for buntanetap to treat neurodegenerative diseases, including Parkinson's and Alzheimer's diseases, with longer treatment regimens," said Maria Maccecchini, Founder, President, and CEO of Annovis Bio.
The company had 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.
According to the company, 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.
Buntanetap (previously known as ANVS401 or Posiphen) is an oral translational inhibitor of neurotoxic aggregating proteins, which mode of action leads to lower levels of neurotoxic proteins and consequently less toxicity in the brain.
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