Enanta Pharmaceuticals has recently released the results from the second phase of its INTREPID trial, which studied EDP-305 as a treatment for primary biliary cholangitis (PBC). The results were positive, as the primary and secondary endpoints were met.
About Primary Biliary Cholangitis (PBC)
PBC is a liver disease that is characterized by progressive damage of the bile ducts in the liver. This damage leads to cirrhosis that has the potential to cause liver failure. Initial symptoms include fatigue, itching, darkening of the skin, dry mouth, pain in the muscles and joints, and small bumps under the skin. As the disease progresses, symptoms evolve into jaundice, swelling of the feet and legs, diarrhea, internal bleeding, an underactive thyroid, a distended abdomen, and fragile bones. The cause of these symptoms is unknown, but medical professionals suspect that an environmental trigger causes an autoimmune response that attacks the liver.
About the Study
The INTREPID study was twelve weeks long, double-blind, placebo controlled, and randomized. It was intended to evaluate the safety, efficacy, tolerability, and pharmacokinetics of EDP-305. The primary endpoint was 20% reduction of ursodeoxycholic acid, which was met. In fact, there was a 45% reduction, compared to only 11% in the placebo-arm. Secondary endpoints were changes from the baseline in liver enzymes ALT, AST, and GGT, all of which were met as well. Fortunately, all adverse effects were mild to moderate.
While this study was a success, researchers are turning their focus towards EDP-305 as a treatment for NASH. Because PBC already has a second-line treatment, those working on this trial feel that this medication’s effects will be more useful in the treatment for NASH, which has an unmet medical need. Hopefully EDP-305 will be able to better the lives of those with NASH.
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