A data and safety monitoring board (DSMB) has reviewed the current data for Hepion Pharmaceuticals’ (NASDAQ:HEPA) ASCEND-NASH Phase 2b trial with rencofilstat and issued a “study may proceed without modification” clearance.
This is the first planned DSMB meeting. It occurred on schedule, and all labs, EKGs, adverse events, and protocol deviations were reviewed, focusing on any potential safety signals from the placebo-controlled trial.
Hepion is on track to complete enrollment in ASCEND-NASH in the first quarter of 2024, and the initial subjects are now approaching the later stages of the 12-month trial.
“To date we have been pleased with the safety profile for all doses of rencofilstat in both healthy subjects and those with advanced NASH, most recently supported by the lack of safety signals in the four-month Phase 2 ALTITUDE-NASH liver function trial,” Todd Hobbs, M.D. and CMO of Hepion, said in a statement.
“Having an external group of experts review unblinded safety data from the ongoing and larger ASCEND-NASH biopsy trial and issue this clearance to continue without changes is reassuring for both Hepion and those subjects currently enrolled in the trial,” he added.
