ContraVir Pharmaceuticals Inc (NASDAQ:CTRV) stock continued to rise Friday after the company shared positive preclinical data on promising drug candidate CRV431 to treat nonalcoholic steatohepatitis (NASH).
NASH is liver inflammation and damage caused by a buildup of fat in the liver. Patients with this disease are often told they have a "fatty liver."
Shares in the Edison, New Jersey-based biotech were up nearly 14.3% at $8.09. The shares had rocketed nearly 136% early Thursday to $11.83 before closing at $7.
The company said in a statement that CRV431, an inhibitor of a family of proteins called cyclophilins, “significantly decreased” the extent of scarring in a second mouse model of liver fibrosis.
Fibrosis, or scarring, of the liver is a hallmark symptom of NASH that results in impaired liver function.
Intercept Pharmaceutical Inc’s (NASDAQ:ICPT) obeticholic acid, a semi-synthetic bile acid drug approved for the treatment of primary biliary cholangitis, a rare liver disease where a patient’s bile ducts are slowly destroyed, was used as a comparator drug in the study and failed to show a decrease in fibrosis.
“This is the second animal model, and the fifth study overall, in which CRV431 consistently demonstrated a statistically significant reduction in fibrosis,” said ContraVir CEO Robert Foster. “In addition, this study showed that CRV431 reduced fibrosis where OCA, a drug approved for PBC with potential to treat additional liver diseases, such as NASH, did not.”
The trial carried out at the Scripps Research Institute is the fifth to demonstrate CRV431’s statistically significant anti-fibrotic efficacy, but the first to use the CCl4 animal model.
Previously, four separate preclinical studies demonstrated similar effects of CRV431 in a STAM NASH model. In the STAM NASH model, liver fibrosis is induced in mice by giving them streptozotocin and pumping them with a high fat diet starting at three weeks of age. All four studies showed statistically significant reductions in fibrosis scores.
Superior efficacy profile
“CRV431’s superior efficacy profile in this model, is very promising and is especially exciting given CRV431’s additional anti-viral and anti-cancer properties we have demonstrated in other preclinical studies,” said Dr Foster. “We will continue to study additional models of fibrosis in preparation for future NASH clinical trials.”
ContraVir is developing CRV431 for NASH, fibrosis, and other lover diseases such as viral hepatitis and liver cancer.
A Phase 1, single ascending dose study of CRV431 was safe and well tolerated in humans.
Worldwide liver cancer is the second leading cause of cancer-related deaths, with as many as 750,000 deaths annually.
Contact Uttara Choudhury at [email protected]