In a mid-stage study, Enanta Pharmaceuticals Inc.'s experimental treatment EDP-305 reduced the levels of a certain enzyme in the blood associated with liver damage.
In the 12-week phase 2a trial called Argon-1, a 2.5-milligram dose of EDP-305 met the main goal of significantly reducing alanine transaminase — an enzyme found in kidney and liver cells — in patients with nonalcoholic steatohepatitis, or NASH, compared to placebo.
NASH is a nonalcoholic fatty liver disease that results in liver inflammation and damage. The condition may lead to complications such as cirrhosis, liver cancer, liver failure or cardiovascular disease.
During the trial, 45% of patients in the EDP-305 arm showed fat reduction greater than or equal to 30%.
The Watertown, Mass.-based biotechnology company expects to start a 72-week phase 2b trial of EDP-305 in NASH patients in the first half of 2020.
Enanta is also evaluating the drug to treat patients with a liver disease known as primary biliary cholangitis, or PBC, in another phase 2 trial called Intrepid. In PBC, bile ducts in the liver become damaged and inhibit the organ's ability to rid the body of toxins, leading to scarring of liver tissue or cirrhosis.
The U.S. Food and Drug Administration granted fast track status to EDP-305 for the treatment of patients with nonalcoholic steatohepatitis with liver fibrosis in January 2017.
