Hepion Pharmaceuticals has called it quits on a Phase IIb trial investigating the biotech’s lead drug candidate for the treatment of non-alcoholic steatohepatitis (NASH).
The US company, which uses artificial intelligence and deep machine learning to develop drugs, cited resource constraints as the reason for shelving the trial called ASCEND-NASH. Hepion stated that it has already “begun wind-down activities”.
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The study was investigating rencofilstat – an oral small molecule that inhibits Cyclophilin B, an important regulator of collagen production. Hepion states that blocking the action of this protein can reduce collagen secretions and fibrotic scarring.
The future of Hepion’s NASH programme was already up in the air following a restructuring plan announced in December 2023. The company announced it was pursuing a new strategy that cut operating costs by 60%. At the time, ASCEND-NASH’s enrolment was already paused, with its viability under evaluation.
A total of 151 subjects were enrolled in the trial against a target of 336. From that cohort, 80 subjects completed the year-on visit.
Hepion’s executive chairman John Brancaccio said: “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 programme and assure that patients are transitioned out of the trial in a safe and compliant manner.”
After pulling the plug on its ASCEND-NASH programme, Hepion said it will continue to explore strategic alternatives.
NASH, also known as metabolic dysfunction-associated steatohepatitis (MASH), is a condition where fat builds up in the liver. This can potentially cause liver damage or cirrhosis.
The first NASH treatment was approved by the US Food and Drug Administration (FDA) last month. Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) gained the agency nod after a race that involved several big pharma players.
According to GlobalData’s patient-based forecast, Rezdiffra is expected to generate $1bn in global sales in 2027.
GlobalData is the parent company of Clinical Trials Arena.
