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Publication Number
US-10272058-B2
Publication Date
2019-04-30
Expiration Date
Abstract
Treatment of intrahepatic cholestatic diseases by therapy with seladelpar or a salt thereof.
Core Innovation
The document describes treatment of intrahepatic cholestatic diseases, including primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), progressive familial intrahepatic cholestasis (PFIC), and Alagille syndrome, using seladelpar (MBX-8025) or a pharmaceutically acceptable salt thereof. Cholestasis is discussed in terms of clinical markers, including alkaline phosphatase (ALP) and γ-glutamyl transpeptidase (GGT). The problem addressed is the need for therapeutic approaches for intrahepatic cholestatic diseases characterized by abnormal cholestasis markers.
Seladelpar (MBX-8025) is described as an orally active, potent PPARδ agonist, expected to reduce cholestasis markers such as ALP and GGT. The document also discusses administration as “seladelpar or a salt thereof” and refers to “therapeutically effective amount” dosing. Preferred dose ranges are summarized as oral dosing, with an example dose range stated in the summary as 5–50 mg/day for adults.
A PBC clinical trial is described in which oral seladelpar produced strong ALP reductions versus placebo at 12 weeks, with improved responder rates reported. The summary indicates responder rates improving up to 100% at 200 mg/day and reports without reported pruritus adverse events. The document further discusses expectations related to dose reduction and additional metabolic marker improvements.
Claims Coverage
Two independent claims are identified: clm-00001 and clm-00009. Across both independent claims, the inventive coverage centers on treating primary biliary cholangitis by administering seladelpar (or a salt thereof) at specific daily doses calculated as seladelpar.
Treating primary biliary cholangitis with 5 mg daily seladelpar
A method of treating primary biliary cholangitis by administering seladelpar or a salt thereof, wherein the daily dose is 5 mg when calculated as seladelpar.
Treating primary biliary cholangitis with 10 mg daily seladelpar
A method of treating primary biliary cholangitis by administering seladelpar or a salt thereof, wherein the daily dose is 10 mg when calculated as seladelpar.
The independent claim coverage is limited to methods for treating primary biliary cholangitis using seladelpar (or a salt thereof) at daily doses of 5 mg or 10 mg calculated as seladelpar.
Stated Advantages
Oral seladelpar is expected to reduce cholestasis markers such as ALP and GGT.
In a PBC clinical trial, oral seladelpar produced strong ALP reductions versus placebo at 12 weeks.
Responder rates were reported to improve up to 100% at 200 mg/day.
Without reported pruritus adverse events in the described trial summary.
Documented Applications
Treatment of intrahepatic cholestatic diseases, including primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), progressive familial intrahepatic cholestasis (PFIC), and Alagille syndrome, using seladelpar (MBX-8025) or a pharmaceutically acceptable salt thereof.
Use in a primary biliary cholangitis (PBC) clinical trial with oral seladelpar administered for 12 weeks, evaluated using an ALP endpoint and responder rates (as described in the partial summary).
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