Mirum Pharma Says EMBARK Phase 2b Study Evaluating LIVMARLI Fails To Meet Endpoints

(RTTNews) - Mirum Pharmaceuticals, Inc. (MIRM) announced Monday top-line results of the Phase 2 EMBARK study evaluating LIVMARLI (maralixibat) oral solution versus placebo given as an adjuvant therapy to Kasai surgery in patients with biliary atresia.

The study did not meet its primary endpoint of mean change in bilirubin from baseline to Week 26, or the key secondary endpoints. Baseline characteristics were well-balanced between the groups. LIVMARLI was generally well-tolerated, with no new safety findings.

The Phase 2b EMBARK study is a randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of LIVMARLI (maralixibat) oral solution in patients with biliary atresia who have undergone a Kasai surgery.