Hepion Pharmaceuticals Receives FDA Fast Track Designation for CRV431 for Treatment of NASH


EDISON, NJ, Nov. 30, 2021 (GLOBE NEWSWIRE) – Hepion Pharmaceuticals, Inc. (NASDAQ: HEPA), a clinical-stage biopharmaceutical company focused on the development of artificial intelligence (“AI”) -based therapeutic drugs for the treatment of alcoholic steatohepatitis (“NASH”) and other liver diseases, announced today that the United States Food and Drug Administration (“FDA”) has granted Fast Track designation to the leading drug candidate company, CRV431, for the treatment of NASH.

The FDA Fast Track designation allows sponsors to access expedited drug approval reviews for serious and potentially life-threatening medical conditions for which there is an unmet medical need. The program is also designed to facilitate drug development by providing for more frequent meetings with the FDA to discuss drug development plans, and the Fast Track designation may lead to expedited approval and / or priority review if certain criteria are filled.

“CRV431 has been studied in healthy subjects during our Phase 1 program, and more recently in subjects with suspected NASH F2 and F3 in our Phase 2a AMBITION study,” commented Todd Hobbs, MD, Medical Director of Hepion. “Given once daily as an oral soft capsule, CRV431 was well tolerated and showed signs of efficacy in NASH in this first phase 2 study. We are now looking forward to launching our larger phase study. 2b on NASH, called “ASCEND-NASH”, in NASH F2 and F3 subjects confirmed by biopsy in the coming months. “

Dr Hobbs continued, “We are fully aware that there remains an urgent global need to develop therapeutic drugs specific to NASH for this potentially fatal disease, for which there is currently no FDA approved drug. Additionally, the American Liver Foundation estimates that at least 5% of the adult American population suffers from NASH. As such, we are very pleased to receive the Fast Track designation from the FDA and look forward to working closely with the Agency as we advance the development of CRV431.

Robert Foster, PharmD, PhD, CEO of Hepion, added, “This Fast Track designation enables early and frequent communication with the FDA that will continue throughout the drug development and review process, which may lead to faster drug approval and patient access to CRV431. Additionally, as part of the FDA’s Fast Track designation for CRV431 in NASH, Hepion will be releasing its expanded access policy in the coming weeks.

About Hepion Pharmaceuticals

The Company’s lead drug candidate, CRV431, is a potent inhibitor of cyclophilins, which are involved in many disease processes. CRV431 is currently in clinical development for the treatment of NASH, with the potential to play an important role in the overall treatment of liver disease – from trigger events through to the end stage of disease. CRV431 has been shown to reduce hepatic fibrosis and tumor burden of hepatocellular carcinoma in experimental models of NASH; and has demonstrated antiviral activities against HBV, HCV and HDV through several mechanisms, in non-clinical studies.

Hepion has created a proprietary AI platform, called AI-POWR ™, which stands for AArtificial intelligence – Pprecision medicine; ohmicros (including genomics, proteomics, metabolomics, transcriptomics and lipidomics); Waccess to the global database; and Rresponse and clinical results. Hepion intends to use AI-POWR ™ to help identify NASH patients who will respond best to CRV431, potentially shortening development times and increasing the delta between the placebo and treatment groups. In addition to using AI-POWR ™ to drive its ongoing NASH clinical development program, Hepion intends to use the platform to identify additional potential indications for CRV431 to expand the footprint of the company in the therapeutic space of cyclophilin inhibition.

Forward-looking statements

Certain statements contained 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”, “anticipate”, “ estimated ”and“ intention ”, 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 these forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue to operate; our need for additional financing; uncertainties in patent protection and litigation; the risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties regarding long and expensive clinical trials, the fact that the results of previous studies and trials may not be predictive of the results of future trials; uncertainties regarding reimbursement from the government or a third party payer; limited sales and marketing efforts and reliance on third parties; and risks associated with failure to obtain FDA clearances or approvals and failure to comply with FDA regulations. As with any drug candidate under development, there are significant risks in the development, regulatory approval and commercialization of new products. There is no guarantee that future clinical trials discussed in this press release will be completed or successful, or that a product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake to update or revise any forward-looking statement. Investors should read the risk factors set out in Hepion Pharmaceuticals Form 10-K for the fiscal year ended December 31, 2020, and other periodic reports filed with the Securities and Exchange Commission.

For more information, please contact:

Stephen kilmer
Hepion Pharmaceuticals Investor Relations
Direct: (646) 274-3580
[email protected]

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