Albireo Pharma (NASDAQ:ALBO) completed patient enrollment in its Phase 2 trial of elobixibat for the treatment of nonalcoholic steatohepatitis (NASH) and nonalcoholic fatty liver disease (NAFLD).
The trial enrolled 47 patients and is designed to assess the safety and efficacy of once daily elobixibat over a period of 16 weeks. The primary endpoint is change from baseline in serum low-density lipoprotein cholesterol.
Albireo expects to report topline results mid-year.
“This is the first clinical trial ever conducted in both NASH and NAFLD patients with an ileal bile acid transporter inhibitor,” Ron Cooper, Albireo’s president and CEO, said in a statement.
“Our clinical and preclinical data indicate there is a strong rationale for bile acid modulation by ileal bile acid transporter inhibition as a therapeutic approach in NASH, given that this approach could have a positive effect on a combination of parameters like lipids, glucose, liver inflammation, liver fibrosis and elevated bile acids, a favorable tolerability profile, and once-a-day oral dosing for ease of use,” he added.
