Mirum reports EMBARK Phase 2b study for biliary atresia did not meet endpoints

Earlier, Mirum Pharmaceuticals announced top-line results of the Phase 2 EMBARK study evaluating Livmarli 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. “We are disappointed in the outcome of the study in this post-surgery, high-need disease setting. We are grateful to the patients, families, and clinicians who participated in the study and advanced the science around this rare liver disease,” said Chris Peetz, president and CEO at Mirum. In late morning trading following this morning’s announcement, Mirum shares are down $6.65, or 19%, to $28.28.