Hepion Pharmaceuticals Initiates Wind-Down Activities in Phase 2b ‘ASCEND-NASH’ Trial

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Hepion Pharmaceuticals has initiated wind-down activities in its Phase 2b ASCEND-NASH Trial due to resource constraints. The trial, evaluating the safety and efficacy of rencofilstat for NASH treatment, had 151 subjects randomized with 80 completing their Day 365 visits. The company plans to explore strategic alternatives following this decision.

Positive

• None.

Negative

• Resource constraints leading to wind-down of Phase 2 NASH trial
• Low probability of generating relevant efficacy data with current cash resources
• Transitioning patients out of the trial due to program wind-down

Financial Analyst

The announcement by Hepion Pharmaceuticals to cease the ASCEND-NASH trial is a pivot that warrants attention from a financial perspective. The company's decision is attributed to resource constraints, which highlights a critical liquidity situation. This development could indicate cash burn issues that are common in the biopharmaceutical sector but raise red flags for investors regarding the company's sustainability. The fact that they are exploring strategic alternatives suggests they might be looking at options such as partnerships, mergers, or asset sales, which could either dilute current shareholders' equity or potentially bring an infusion of capital if well-negotiated. Investors should closely monitor the management's next steps, as they will be pivotal for the company's future and the stock's performance.

Medical Research Analyst

From a scientific angle, halting the Phase 2b trial of rencofilstat in NASH patients is a setback not only for Hepion but also for the advancement of NASH treatments. The trial's cessation due to funding rather than efficacy or safety concerns does provide a silver lining that the investigational drug wasn't facing clinical issues. Nevertheless, this underscores the importance of adequate financial planning in clinical research. For the industry, this event may serve as a cue to reassess the economic models of drug development, especially for diseases like NASH, which has a significant unmet medical need yet is a complex and costly condition to tackle.

EDISON, N.J., April 19, 2024 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company that has been developing a treatment for non-alcoholic steatohepatitis (“NASH”), hepatocellular carcinoma (“HCC”), and other chronic liver diseases, today announced that it has begun wind-down activities in its ASCEND-NASH Trial, while continuing to explore strategic alternatives, as previously announced in December 2023.

ASCEND-NASH is a Phase 2b, randomized, multi-center, double-blinded study with first patient screened in August 2022, to evaluate the safety and efficacy of rencofilstat dosed for 12 months, with a target enrollment of 336 subjects. Enrollment was paused in April 2023, with 151 subjects randomized. To date, approximately 80 subjects have completed their Day 365 visits and are evaluable for both safety and efficacy. An additional 40 subjects will provide significant safety data for evaluation. These patients will be added to our existing safety database.

“We are disappointed to announce the wind-down of our Phase 2 NASH trial, which we attribute entirely to resource constraints,” said John Brancaccio, Executive Chairman of Hepion. “The Company remains committed to its strategic alternative efforts previously announced in December 2023. 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 and assure that patients are transitioned out of the trial in a safe and compliant manner. There were no safety concerns observed for rencofilstat in the ASCEND-NASH trial.”

About Hepion Pharmaceuticals

Rencofilstat, is a potent inhibitor of cyclophilins, which are involved in many disease processes. Rencofilstat has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental disease models. In November 2021, the U.S. Food and Drug Administration (“FDA”) granted Fast Track designation for rencofilstat for the treatment of NASH. That was followed in June 2022 by the FDA’s granting of Orphan Drug designation to rencofilstat for the treatment of HCC.

Hepion has created and maintains a proprietary Artificial Intelligence deep machine learning (“AI/ML”) platform designed to better understand disease processes and identify patients that are rencofilstat responders. This AI/ML has the potential to shorten development timelines and increase the observable differences between placebo and treatment groups. In addition, Hepion’s AI/ML can be used to further NASH and HCC clinical development programs and identify other potential therapeutic indications for cyclophilin inhibition with rencofilstat.

Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated,” and “intend,” among others. These forward-looking statements are based on Hepion Pharmaceuticals’ current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals’ Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission.

For further information, please contact:
Hepion Pharmaceuticals
732-902-4000
info@hepionpharma.com

FAQ

What trial is Hepion Pharmaceuticals winding down?

Hepion Pharmaceuticals is winding down its Phase 2b ASCEND-NASH Trial.

What is the reason for the wind-down of the trial?

The wind-down is attributed to resource constraints.

How many subjects were randomized in the ASCEND-NASH trial?

151 subjects were randomized in the trial.

What is the target enrollment for the ASCEND-NASH trial?

The target enrollment is 336 subjects.

Who is the Executive Chairman of Hepion Pharmaceuticals?

John Brancaccio is the Executive Chairman of Hepion Pharmaceuticals.