Acasti Pharma to proceed with Phase 3 study of GTX-104

Acasti Pharma announced that it received a Type C written meeting response and clarifying feedback from the United States FDA on Acasti’s proposed Phase 3 Safety Study for GTX-104. The FDA provided additional comments on the company’s development plan that, pending submission of the final clinical protocol and FDA approval of same, will allow Acasti to proceed with the initiation of a Phase 3 safety clinical trial in aneurysmal Subarachnoid Hemorrhage patients. The FDA concurred with the suitability of the 505(b)(2) regulatory pathway with the selected Reference Listed Drug Nimotop oral capsules, and that Acasti’s GTX-104-002 PK study may have met the criteria for a scientific bridge. Based on FDA’s proposed Phase 3 Study Design, the company will target enrollment of aSAH patients in a 1:1 randomized trial with oral nimodipine, to be conducted in an estimated 25-30 sites in the U.S.A. The FDA confirmed the use of the Hunt and Hess scale to stratify patients based on severity. The primary endpoint is safety, and it will be measured as the percentage of significant adverse events of hypotension related to study drugs in both arms.