Cash crunch forces Hepion to halt mid-stage MASH study of rencofilstat

2024-04-22

临床2期上市批准

Hepion Pharmaceuticals’ shares lost a third of their value after the company decided to halt its mid-stage programme for rencofilstat in metabolic dysfunction-associated steatohepatitis (MASH) due to financial constraints. The drugmaker will seek strategic alternatives to pursue further development of the cyclophilin inhibitor.

The Phase IIb ASCEND-NASH study kicked off in August 2022 and planned to investigate the safety and efficacy of rencofilstat versus placebo over 12 months in 336 participants. However, enrolment was stopped in April last year after 150 people were randomised. Hepion noted that nearly 80 participants had currently completed the one-year follow-up, with an additional 40 lined up for safety assessments.

“Given the number of enrolled [MASH] 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,” explained Hepion’s executive chairman John Brancaccio. He confirmed there were no safety issues associated with the drug in the study.

Hepion had earlier announced a restructuring plan to preserve capital by slashing operating costs by approximately 60%, thus extending its cash runway into the second quarter of 2025.

Several players, including big pharmas such as Eli Lilly and Novo Nordisk, are battling it out in the competitive MASH arena. However, the MASH debutant crown was snatched by Madrigal after clinching FDA approval for Rezdiffra (resmetirom) last month (for related analysis, read KOL Views Q&A: Leading endocrinologist lays out challenges ahead as Madrigal launches Rezdiffra in MASH).

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