Percheron Therapeutics (ASX:PER) has announced the completion of a nine-month toxicology study in non-human primates for its lead program, avicursen.
The nine-month toxicology study is a critical regulatory requirement for future clinical trials and commercialisation in the US. The company said the study commenced in March 2023 and is now fully completed, with a final study report in hand.
Percheron said the study results remain broadly consistent with the earlier six-month study. It said it expects to discuss the results with the US FDA in early calendar year 2025, with the goal of lifting the clinical hold in the US.
During previous regulatory discussions, the FDA communicated to the company the requirement for a nine-month non-rodent toxicology study before any clinical trial involving dosing beyond six months.
Percheron said that because avicursen is intended to be administered over an extended period, the study effectively represents a prerequisite for conducting clinical trials in the US.
“We are very pleased to have this important piece of work completed on schedule,” said Percheron CEO Dr James Garner. “The results seem to us, and to our consultants and advisors, to be consistent with earlier observations, which we expect to have positive implications for the future development of avicursen. Given the impending availability of clinical data from the phase IIb clinical trial of avicursen in December 2024, we will likely target our regulatory discussions with the FDA for early CY2025, so as to present the agency with the strongest possible package of data.”
