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Publication Number
US-10478411-B2
Publication Date
2019-11-19
Expiration Date
Abstract
Treatment of intrahepatic cholestatic diseases by therapy with seladelpar or a salt thereof.
Core Innovation
The document describes treating intrahepatic cholestatic diseases by administering seladelpar or a pharmaceutically acceptable salt, including seladelpar L-lysine dihydrate. Seladelpar is described as a potent PPARδ agonist that lowers cholestasis biomarkers ALP and GGT, supporting a reduction of cholestasis.
The document further describes early clinical evidence for primary biliary cholangitis (PBC), including a Phase 2 study in which oral seladelpar produces rapid, potent ALP decreases versus placebo as the primary endpoint. The report also includes high responder rates and reversible asymptomatic transaminase elevations, and states that no pruritus increase is reported in that early study context.
The document also includes nonlimiting dosing and formulation guidance for intrahepatic cholestatic disease, including example dosing ranges and preferred dose ranges expressed in mg/day. The partial content specifically references daily dose guidance, and the overall invention centers on dosing seladelpar or a seladelpar salt in order to treat cholestatic disease.
Claims Coverage
The partial set includes two independent claims directed to methods of treating primary sclerosing cholangitis using seladelpar or a salt thereof, each characterized by a specific daily dose expressed when calculated as seladelpar. Across these independent claims, the main inventive features are the indication and a fixed daily seladelpar-equivalent dose.
Treating primary sclerosing cholangitis with a 5 mg daily dose calculated as seladelpar
A method of treating primary sclerosing cholangitis by administering seladelpar or a salt thereof, where the daily dose of seladelpar or a salt thereof is 5 mg, when the dose is calculated as seladelpar.
Treating primary sclerosing cholangitis with a 10 mg daily dose calculated as seladelpar
A method of treating primary sclerosing cholangitis by administering seladelpar or a salt thereof, where the daily dose of seladelpar or a salt thereof is 10 mg, when the dose is calculated as seladelpar.
Within the provided independent claims, the claimed coverage is limited to methods for primary sclerosing cholangitis using seladelpar or a salt at daily doses of 5 mg or 10 mg, respectively, with the dose calculated as seladelpar.
Stated Advantages
Seladelpar is described as lowering cholestasis biomarkers ALP and GGT, supporting reduction of cholestasis.
Oral seladelpar is reported to produce rapid, potent ALP decreases versus placebo as the primary endpoint in a Phase 2 PBC study.
The document reports high responder rates.
The document reports reversible asymptomatic transaminase elevations.
The document states that no pruritus increase is reported in the early study context.
Documented Applications
Treatment of primary biliary cholangitis (PBC) in a Phase 2 study, assessed using oral seladelpar with ALP as the primary endpoint [procedural detail omitted for safety].
Treatment of primary sclerosing cholangitis (PSC) by administering seladelpar or a salt thereof, including seladelpar L-lysine dihydrate as described in the partial claim set.
Treatment of intrahepatic cholestatic diseases generally by administering seladelpar or a pharmaceutically acceptable salt, including seladelpar L-lysine dihydrate.
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