Hepion Pharmaceuticals Announces FDA Approval of IND Application for CRV431 for Treatment of Liver Cancer

– New IND Expands Liver Disease Pipeline for CRV431 –

– IND authorization allows CRV431 to go directly to phase 2 for the treatment of hepatocellular carcinoma –

– The new IND offers a complementary therapeutic approach to the treatment of NASH and liver cancer with a single, single-dose oral agent –

EDISON, NJ, Dec. 21, 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 accepted its application for an investigational new drug (“IND “) For CRV431, a new liver-targeting cyclophilin inhibitor, for the treatment of hepatocellular carcinoma (” HCC “).

On July 29, 2019, Hepion received FDA clearance from an IND to initiate the study of CRV431 for the treatment of NASH. To date, Hepion has completed phase 1 studies in healthy volunteers and more recently reported positive data from its phase 2a trial “AMBITION” in suspected F2 and F3 subjects, where CRV431 was well tolerated. and all of the primary endpoints have been met. A larger phase 2b NASH study involving more than 300 subjects with matched liver biopsies, called “ASCEND-NASH”, is expected to be launched in 2022. ASCEND-NASH will assess the effects of CRV431 on the histological parameters of steatosis and steatosis. hepatic fibrosis over a 12 month period. .

“Liver cancer is the sixth most common cancer in the world and the second leading cause of cancer death. “¹ commented Todd Hobbs, MD, medical director of Hepion. “The most common form of liver cancer is HCC, which accounts for about 90% of all liver cancers. The main risk factors associated with the development of HCC include NASH, liver fibrosis and cirrhosis, viral hepatitis, chronic alcohol use, and metabolic syndrome. As the global prevalence of NASH increases, the incidence of HCC resulting from NASH is also increasing. About 25-30% of NASH-related HCCs develop in the absence of cirrhosis and, therefore, occur without many of the symptomatic warning signs of this aggressive form of cancer. An orally administered drug that simultaneously targets NASH and HCC would offer an advantageous therapeutic strategy for patients with these life-threatening conditions. The new potential of CRV431 stems from its pleiotropic pharmacological activities and its ability to target the liver, making it an ideal drug candidate for the treatment of liver disease.

Dr Hobbs continued, “Another potentially important benefit is the patient experience while taking CRV431. Most cancer drugs are given by injection and are associated with serious side effects. In contrast, CRV431 is administered orally and has been shown to be well tolerated in clinical trials to date. We are optimistic that CRV431 may provide significant anticancer effects without imposing the additional challenges and distress often associated with anticancer drugs. “

Robert Foster, PharmD, PhD, CEO of Hepion, said: “The increased expression of cyclophilin isoforms has been associated with negative results in HCC. It is important to note that CRV431 potently inhibits many of these isoforms in humans. Cyclophilins are enzymes that regulate many molecular and cellular activities that go wrong in both NASH and HCC. These deregulated activities can lead to aberrations in signal transduction pathways, cell proliferation, cell death, the extracellular environment, including increased fibrosis, energy metabolism, inflammation, and immunity. Therapeutic intervention with the administration of CRV431 may reduce the pathological potential associated with increased activities of cyclophilin in NASH and HCC, potentially allowing a return to a healthier state.

Dr Foster continued, “CRV431 has shown anti-tumor activity in several animal studies, and our research team intensively investigated the specific mechanisms that produced these results. Our investigations revealed interesting direct and indirect effects of CRV431 on cancer cells and tumors. For example, gene expression analyzes demonstrated the ability of CRV431 to attenuate drug resistance pathways and Wnt-β-catenin-Myc signaling, the latter being overactivated by mutation in 30-50% of human HCC tumors. . We recently found too that CRV431 increased lymphocyte infiltration in liver tumors in a manner similar to an immune checkpoint inhibitor, also known as anti-PD-1 antibody, which is considered to be an important anti-tumor approach . We believe that the wide range of pharmacological activities offered by CRV431 in the treatment of NASH and HCC should bode well for further clinical development in these two important indications.

Reference

¹Hepatocellular carcinoma. Nature Towerviews Sayfacilitate Primers seven, 7 (2021).

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 â„¢, 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 â„¢ 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 â„¢ 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]