Mirum’s Long-Term Alagille Data Support Case For Early Filing
Newly public Mirum hopes to file maralixibat for US approval in pruritus due to Alagille syndrome based on Phase IIb data, including long-term extension data reported at AASLD.
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Elobixibat demonstrated ability to reduce LDL cholesterol but is being discontinued in NASH due to its unspectacular overall profile. The firm is staying focused on odevixibat, which could be best-in-class for pediatric liver indications, analysts say.
With $120m in Series A funding, the new company headed by former Lumena execs will advance maralixibat into Phase III in Alagille syndrome and progressive familial intrahepatic cholestasis. Shire acquired Lumena for $260m in 2014, but lost interest in the drug.
Shire's Phase II IMAGO trial of SHP625 in 20 pediatric patients with Alagille syndrome (ALGS) has failed to meet its primary or secondary endpoints.