Albireo Announces FDA Clearance of IND to Commence Phase 2 Trial of Elobixibat

Albireo Pharma (NASDAQ:ALBO) has announced that its investigational new drug application (IND) cleared the 30-day review from the US Food and Drug Administration and can proceed with a Phase 2 clinical trial of elobixibat to treat nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH).

As quoted in the press release:

“The IND and subsequent trial initiation are an important step for our NASH program, as we apply our expertise in bile acids and leverage our novel IBAT platform to address a large unmet medical need,” said Ron Cooper, President and Chief Executive Officer of Albireo. “We have a two-pronged approach for NASH development: advancing elobixibat, a well-characterized IBAT inhibitor, into a Phase 2 trial and continuing to develop novel preclinical compounds.”

NAFLD affects about 25 percent of the world’s population and is a major cause of liver disease. NAFLD may progress to NASH, which is characterized by liver inflammation and damage caused by a buildup of fat in the liver. NASH coincides with high obesity rates and diabetes and is projected to become the leading cause of liver transplants in the United States. NASH patients have a 10-fold greater risk of liver-related mortality, compared with the general population. There is currently no approved pharmacologic treatment for NASH.

There is a strong rationale for bile acid modulation as a therapeutic approach in NASH from an efficacy and safety/tolerability perspective. Key markers in NASH patients include elevated bile acid levels, elevated cholesterol, insulin sensitivity, liver inflammation and liver fibrosis. Clinical and preclinical data indicate that IBAT inhibitors may have a positive impact on these parameters. Elobixibat, an innovative IBAT inhibitor approved last year in Japan for chronic idiopathic constipation, has minimal systemic exposure and a safety database with more than 1,500 patient exposures. Elobixibat could have potential in NASH as either monotherapy or combination therapy.

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