Hepion Pharmaceuticals Inc. (HEPA) has begun winding down activities in its ASCEND-NASH Trial, which is a Phase 2b, randomized, multicenter, double-blinded study evaluating the safety and efficacy of rencofilstat for the treatment of non-alcoholic steatohepatitis (NASH). The decision was made after careful consideration of resource constraints and the low probability of generating sufficient efficacy data to support a registrational trial.
The ASCEND-NASH Trial enrolled 151 subjects, with approximately 80 subjects completing their Day 365 visits and being evaluated for safety and efficacy. An additional 40 subjects will provide significant safety data for evaluation, which will be added to the existing safety database.
“We are disappointed to announce the wind-down of our Phase 2 NASH trial, which we attribute entirely to resource constraints,” said John Brancaccio, Executive Chairman of Hepion. “Given the number of enrolled NASH patients to date and the low probability of generating relevant efficacy data to support a registrational trial with our current cash resources, we have opted to wind down the program and assure that patients are transitioned out of the trial in a safe and compliant manner. There were no safety concerns observed for rencofilstat in the ASCEND-NASH trial.”
In pre-market trading on Monday, HEPA shares were down 28.5% at $1.44.
