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Publication Number
US-10813895-B2
Publication Date
2020-10-27
Expiration Date
Abstract
Treatment of intrahepatic cholestatic diseases by therapy with seladelpar or a salt thereof.
Core Innovation
The invention relates to a method of treating intrahepatic cholestatic diseases by administering seladelpar or a salt thereof. The intrahepatic cholestatic diseases include progressive familial intrahepatic cholestasis (PFIC), primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), and Alagille syndrome (AS).
Seladelpar is described as an orally active PPARδ agonist, and the salt forms of seladelpar are addressed, including seladelpar lysine salts such as seladelpar L-lysine dihydrate salt. The described rationale is that seladelpar reduces cholestasis biomarkers alkaline phosphatase (ALP) and gamma-glutamyl transpeptidase (GGT).
Supporting evidence is described using a PBC Phase 2 study in which oral seladelpar produces rapid and potent ALP reductions and improved responder rates, with generally reversible transaminase elevations. The document further notes additional metabolic improvements and discusses dosing ranges for oral adult therapy and treatment definitions using endpoint markers associated with cholestasis biomarkers.
Claims Coverage
The independent claims cover methods of treating progressive familial intrahepatic cholestasis using seladelpar or a salt thereof at specific daily doses calculated as seladelpar. The inventive features focus on selected daily dose levels, with dependent features further specifying particular salt forms and oral and once-per-day administration constraints.
Daily dose of 5 mg calculated as seladelpar
A method of treating progressive familial intrahepatic cholestasis by administering seladelpar or a salt thereof, where the daily dose is 5 mg when calculated as seladelpar.
Daily dose of 10 mg calculated as seladelpar
A method of treating progressive familial intrahepatic cholestasis by administering seladelpar or a salt thereof, where the daily dose is 10 mg when calculated as seladelpar.
The independent claims define treatment of progressive familial intrahepatic cholestasis by administering seladelpar or a salt thereof at specified daily doses calculated as seladelpar, namely 5 mg or 10 mg. The claim set as a whole further refers to seladelpar salt forms such as seladelpar L-lysine dihydrate and limits administration to oral dosing and once per day in the dependent claims provided.
Stated Advantages
Reduces cholestasis biomarkers alkaline phosphatase (ALP) and gamma-glutamyl transpeptidase (GGT).
Produces rapid and potent ALP reductions.
Improves responder rates.
Generally reversible transaminase elevations.
Provides additional metabolic improvements.
Documented Applications
Treating intrahepatic cholestatic diseases, including progressive familial intrahepatic cholestasis (PFIC).
Treating primary biliary cholangitis (PBC), supported by a PBC Phase 2 clinical study described in the document.
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