An oral translational inhibitor of neurotoxic aggregating proteins (TINAPs), buntanetap (ANVS401 or Posiphen) has a mode of action that causes reduced neurotoxic protein levels.
The latest move comes after the regulatory agency accepted the final protocol and the clinical development plan.
In addition, the FDA approved the usage of Annovis’ new large-scale batch of good manufacturing practice material and noted that the chronic toxicology in rats and dogs was safe and sufficient to support long-term human trials spanning decades versus prior restriction of one month.
After holding a successful Type B meeting with the FDA for buntanetap’s continued development in PD this year, the company sought consideration from the agency on modifying the accepted development plan, finalising Phase III trial protocol and advancing with longer-duration trials.
All the safety findings in mice, rats, dogs and more than 200 humans; chemistry, manufacturing and controls package for new large-scale batch and complete data obtained over the years for Alzheimer’s disease (AD) programme that is also related to Parkinson’s programme, formed part of the submission package.
The double-blind, placebo-controlled, randomised Phase III trial will analyse the safety, efficacy and tolerability of two varying doses of buntanetap or placebo in early Parkinson’s patients.
The trial subjects will be enrolled at 100 sites in the US and European Union to receive oral once-daily doses of either 10mg, 20mg buntanetap or placebo capsules for six months.
Annovis Bio founder, president and CEO Maria Maccecchini said: “We are pleased that the FDA has approved our clinical trial design in early PD patients and called it a well-designed study.
“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.”
According to a Phase IIa trial, buntanetap offered a statistically significant improvement in motor function in PD patients and cognition in AD patients.
Furthermore, the drug was found to be well-tolerated and safe with pharmacokinetics consistent with levels seen earlier in humans, meeting the trial’s primary and secondary endpoints.