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Hepion Pharmaceuticals (NASDAQ:HEPA) said it has begun winding down its ASCEND-NASH Phase 2 study for its drug rencofilstat as it continues to explore strategic alternatives for the company.
“We are disappointed to announce the wind-down of our Phase 2 NASH trial, which we attribute entirely to resource constraints,” said Hepion Executive Chairman John Brancaccio, in a statement.
“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,” Branaccio added, noting that no safety concerns were observed in the study.
The drug developer said in December that it planned to cut operating costs by around 60% to preserve capital, which would extend its cash runway into Q2 2025. It added that it intended to move ahead with the ASCEND-NASH study “once the clinical trial is fully funded or a strategic transaction has been entered into.”
Hepion has been testing reconfilstat for the treatment of non-alcoholic steatohepatitis, or NASH, which is also known as metabolic dysfunction-associated steatohepatitis, or MASH.
Hepion is one of several companies working on therapies for NASH/MASH. Other drug developers in the field include Eli Lilly (LLY), Novo Nordisk (NVO), GSK (GSK), Viking Therapeutics (VKTX), Ascletis (OTCPK:ASCLF), Akero Therapeutics (AKRO), 89bio (ETNB), Sagimet Biosciences (SGMT), Galectin Therapeutics (GALT), Gilead (GILD), Galmed (GLMD), Altimmune (ALT), Ionis (IONS), Terns Pharma (TERN), Inventiva (IVA) and Arrowhead (ARWR).
In March, Madrigal Pharmaceuticals (MDGL) became the first company to win FDA approval for a treatment for the condition, with the accelerated approval of its drug Rezdiffra.