Hepion’s NASH trial hangs in the balance as biotech cuts costs by 60%, CEO departs

Hepion Pharmaceuticals is trying to stay afloat as the biotech’s CEO hits the exit and the company seeks strategic alternatives, leaving the fate of a phase 2b trial for non-alcoholic steatohepatitis (NASH) up in the air.

The New Jersey-based biotech’s board has approved a plan designed to slash operating costs by 60%, extending the company’s cash runway into the second quarter of 2025.

Hepion’s head honcho Robert Foster, Ph.D., has also resigned, citing personal reasons. Chief Financial Officer John Cavan has stepped up and will lead the biotech as interim CEO.

The AI-driven company is looking at a range of alternatives—an acquisition, merger, reverse merger, sale of assets, licensing, and others—that will maximize stockholder value “within the current financial environment and NASH drug development landscape,” according to a Dec. 7 release.

In a response to questions from Fierce Biotech about whether the restructuring plan will lead to layoffs, Hepion provided the following statement from interim CEO Cavan: "Our restructuring is intended to improve Hepion's expenditures, capital structure, and liquidity while continuing to develop Hepion's lead therapy, rencofilstat, currently in a Phase 2b trial, for liver disease."

Hepion’s stock has sunk 13% since market open this morning, resting at $2.80 per share as of 10:45 a.m. ET.   

The fate of Hepion’s phase 2b clinical trial called ASCEND-NASH hangs in the balance. The study is assessing rencofilstat, Hepion’s lead drug candidate designed to inhibit cyclophilins, a protein family involved in several disease processes. The drug has received FDA fast-track status for NASH and orphan drug designation in hepatocellular carcinoma.

Hepion management is evaluating the trial given the current market environment and said it will continue patient enrollment once the study is fully funded or the company has entered a strategic transaction. Currently, 131 patients are being treated in ASCEND-NASH and the biotech says it plans to complete treatment for those patients. The study has a primary completion date in May 2025, according to ClinicalTrials.gov.

This spring, the company claimed success from a separate phase 2 NASH trial also evaluating rencofilstat. Unlike ASCEND, the trial lacked a control arm, relying on an investigational diagnostic and mainly achieving significant results only at the highest dose level. ASCEND could provide a clearer picture of whether or not Hepion has a chance of bringing rencofilstat to market.  

The NASH space has exploded in the last ten years, with the condition—which is commonly associated with obesity and can lead to liver damage—affecting tens of millions of Americans. Numerous attempts have been made to bring a NASH drug to the FDA finish line, but many companies have come up short thus far. Genfit, Novo Nordisk, Akero Therapeutics, Bristol Myers Squibb, Conatus/Novartis and others have failed to make their therapies work well enough and safe enough in trials to warrant an approval.

However, Madrigal Pharmaceuticals appears to be changing the tide, submitting its once-daily oral thyroid hormone receptor to the FDA via a rolling submission this summer. Analysts have agreed that Madrigal’s treatment, dubbed resmetirom, is likely to be the first NASH treatment to snag approval. At the same time, obesity blockbusters from Novo Nordisk and Eli Lilly are also emerging as potential options in NASH.