Hepion Pharmaceuticals initiates wind-down activities in phase IIb ‘ASCEND-NASH’ trial.

ASCEND-NASH is a Phase IIb, randomized, multi-center, double-blinded study with first patient screened in August 2022, to evaluate the safety and efficacy of rencofilstat dosed for 12 months, with a target enrollment of 336 subjects. Enrollment was paused in April 2023, with 151 subjects randomized. To date, approximately 80 subjects have completed their Day 365 visits and are evaluable for both safety and efficacy. An additional 40 subjects will provide significant safety data for evaluation. These patients will be added to our existing safety database.

“We are disappointed to announce the wind-down of our Phase II NASH trial, which we attribute entirely to resource constraints,” said John Brancaccio, Executive Chairman of Hepion. “The Company remains committed to its strategic alternative efforts previously announced in December 2023. 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.”