Edison, New Jersey-based biopharmaceutical company Hepion Pharmaceuticals Inc. (HEPA:NASDAQ), which focuses on the development of therapeutic drugs for the treatment of liver disease arising from non-alcoholic steatohepatitis (NASH), yesterday announced that CRV431, an anti-fibrotic agent, prevented the development of liver cirrhosis in a highly aggressive, preclinical model of liver disease.
The study was conducted by Physiogenex S.A.S., a Contract Research Organization (CRO) based in France. In the study, Hepion reported that "rats were administered the hepatotoxic compound, thioacetamide, for nine weeks to induce liver injury and fibrosis, in combination with either CRV431 or vehicle control for the entire study period, and that blinded, histopathological analysis of the livers was then conducted at the end of the study period."
The firm noted that "in the vehicle control group, 50% of the 10 animals developed cirrhosis, a severe form of liver disease that includes maximum levels of fibrotic scarring (F4 fibrosis; Kleiner scoring system), and in contrast, none of the 10 CRV431-treated rats developed cirrhosis."
Hepion's CEO Dr. Robert Foster commented, "These findings are an important preclinical milestone for CRV431 because thioacetamide administration to rats is recognized to produce among the most severe liver disease of all experimental models. This model was a rigorous test of CRV431's anti-fibrotic activity...The results align with previous findings in other experimental models and highlight the tremendous potential of CRV431 as a treatment for liver diseases, including NASH, where progression to cirrhosis is a primary medical concern. Every fibrosis study that we have conducted thus far, whether in animals or in human liver slices, has demonstrated CRV431's strong anti-fibrotic activity, contributing to a body of preclinical efficacy data that complements our ongoing human clinical trials."
Less than two weeks ago, the firm announced findings from a preclinical study where CRV431, a novel cyclophilin inhibitor, significantly decreased the extent of liver fibrosis in a highly regarded, Western Diet (WD) animal model of NASH.
The firm noted in the release that this WD model, which was developed in the laboratory of Dr. Scott Friedman at Icahn School of Medicine at Mount Sinai, New York, employs a high-fat, high-fructose and high-cholesterol diet in combination with carbon tetrachloride (CCl4) to cause significant fibrosis and hepatocellular carcinoma in mice. The company claimed in the report that "the model replicates many of the metabolic and histologic features of human NASH."
CEO Dr. Foster remarked, "CRV431 has potently and consistently reduced liver fibrosis in every experimental model in which CRV431 has been examined...A total of seven studies spanning four experimental models and three independent testing sites have now shown CRV431 to decrease liver fibrosis arising from a variety of dietary, chemical, and biochemical insults. These findings include previously reported positive results in human liver samples as examined by precision cut liver slice methodologies, or PCLS...Taken together, these studies suggest that CRV431 may be most effective in advanced stages of NASH where fibrotic activities are highly active. We are building one study upon another to drive our data portfolio, and the results continue to be outstanding. We plan to continue with many additional studies conducted in parallel with our clinical programs to develop a thorough understanding of this important mode of action in liver disease."
Hepion Pharmaceuticals Inc., formerly ContraVir Pharmaceuticals Inc., is a clinical-stage biopharmaceutical company headquartered in Edison, New Jersey. The company indicates that it is focused on the development of targeted therapies for liver disease arising from non-alcoholic steatohepatitis (NASH) and chronic hepatitis virus infection (HBV, HCV, HDV). "Hepion's lead drug candidate, CRV431, reduces liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH. Preclinical studies also have demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms. These diverse therapeutic activities result from CRV431's potent inhibition of cyclophilins, which are involved in many disease processes. Currently in clinical phase development, CRV431 shows potential to play an important role in the overall treatment of liver disease - from triggering events through to end-stage disease," the company stated.
Hepion Pharmaceuticals Inc. began the day with a market capitalization of about $8.5 million with around 3.454 million shares outstanding. The stock has a 52-week price range of $2.00-39.20. This morning, HEPA shares opened greater than 75% higher at $4.30 (+$1.85, +75.51%) over yesterday's $2.45 closing price. The stock has traded today between $3.51 and $4.55/share on extremely high volume and is currently trading at $3.52 (+$1.10, +45.39%).
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