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Phase 2 Trial of Elobixibat for NAFLD/NASH Treatment Imminent
Albireo Pharma, Inc., a clinical-stage orphan pediatric liver-disease company, has received investigational new drug application (IND) clearance from the FDA for elobixibat. The first-in-class, once-daily, orally available ileal bile acid transporter (IBAT) inhibitor is for treatment of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH).
NAFLD, a major cause of liver disease, affects approximately one-quarter of the world’s population. It can progress to NASH––liver inflammation and damage from fat buildup in the liver––which is expected to become the leading cause of liver transplants in the U.S. Currently, there are no approved treatments for the condition.
Key markers in patients with NASH include elevated bile-acid levels, elevated cholesterol, insulin sensitivity, and liver inflammation and fibrosis. Data indicate that IBAT inhibitors may have a positive effect on these. Elobixibat, a novel IBAT inhibitor, has minimal systemic exposure, and may have potential in NASH treatment as monotherapy or combination therapy.
The phase 2 randomized, double-blinded, placebo-controlled, multicenter, clinical trial will assess the efficacy and safety of elobixibat in approximately 46 adults with biopsy-confirmed NASH or a suspected diagnosis of NAFLD/NASH. Patients will receive elobixibat 5 mg once daily for 16 weeks.
The primary endpoint is the assessment of change in low-density lipoprotein (LDL) cholesterol, and secondary endpoints include change in liver fat as seen on imaging, and levels of alanine transaminase and serum bile acids. The study is expected to begin in the second quarter of 2019, with results planned for mid-2020.
Source: Albireo Pharma, April 11, 2019