Mirum Pharmaceuticals (MIRM) said Thursday that volixibat has received breakthrough therapy designation from the US Food and Drug Administration as a potential treatment for cholestatic pruritus related to primary biliary cholangitis.
The company said the designation is based on the interim analysis of a phase 2b study that demonstrated "statistically significant" improvement in patients treated with volixibat compared with placebo.
The study's confirmatory portion is ongoing, with enrollment expected to be completed in 2026, the company said.
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