Sector News

New analysis encourages Intercept to refile NASH drug for approval

July 14, 2022
Life sciences

A drug being tested against a liver disease thought to affect millions of people continues to hold up in a large clinical trial, according to its developer, New Jersey-based Intercept Pharmaceuticals.

The trial has enrolled thousands of patients with nonalcoholic steatohepatitis, or NASH, a disease characterized by a buildup of fat in the liver that progressively scars the organ. NASH is often asymptomatic until later stages, making it more difficult to diagnose. Yet, this “silent” disease has become one of the leading causes for liver transplants in the U.S.

Drug companies large and small have been spent more than a decade trying to develop the first approved treatment for NASH. In that race, Intercept and its candidate, known as obeticholic acid or OCA for short, have held a leading position.

In early 2019, OCA became the first drug to succeed in a Phase 3 study of NASH patients. The trial, named REGENERATE, enrolled participants with moderate to severe liver scarring, and found that a significantly greater percentage of those given a high dose of Intercept’s drug — as opposed to a placebo — had their liver scarring improve without their NASH getting worse. READ MORE

By Jacob Bell

Source: biopharmadive.com

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