Mirum Pharmaceuticals to discontinue OHANA study of volixibat in ICP

Mirum Pharmaceuticals has announced the decision to discontinue the OHANA study of volixibat in intrahepatic cholestasis of pregnancy due to enrollment feasibility. ICP is a setting of cholestasis during pregnancy with pruritus and elevated bile acid levels that can lead to fetal complications. In an interim analysis, patients treated with volixibat saw meaningful reductions in serum bile acids and pruritus. However, due to the challenges in enrollment in this high-risk pregnancy setting, Mirum has decided to discontinue OHANA, which allows the company to prioritize other programs. Mirum is continuing to advance its broad pipeline of indications where LIVMARLI and volixibat have the potential for life-changing impact for patients. Key upcoming milestones include: LIVMARLI anticipated approval in Europe for cholestatic pruritus in patients with Alagille syndrome two months of age and older, by year end 2022; LIVMARLI sNDA application for pruritus in patients with progressive familial intrahepatic cholestasis, expected in first quarter 2023; Volixibat interim analysis in PSC, expected mid-year 2023; Volixibat interim analysis in PBC, expected second half 2023; LIVMARLI Phase 2b data in biliary atresia expected second half 2023; Mirum reiterates revenue expectation of $70 million net product revenue, $72 million total revenue for 2022, and current balance sheet supporting growth through cash flow positive operations.