Annovis Bio, Inc., a company addressing neurodegenerative diseases, announced that they 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.
Buntanetap (previously known as ANVS401 or Posiphen) is an oral translational inhibitor of neurotoxic aggregating proteins (TINAPs), which mode of action leads to lower levels of neurotoxic proteins and consequently less toxicity in the brain. In a Phase 2a clinical trial in AD and PD patients, treatment with buntanetap resulted in statistically significant improvement in motor function in PD patients and cognition in AD patients. Additionally, the drug was well-tolerated and safe, and its pharmacokinetics were found to be in line with levels measured earlier in humans, meeting both the primary and secondary endpoints.