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Publication Number
US-11596614-B2
Publication Date
2023-03-07
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 treated conditions include primary biliary cholangitis, primary sclerosing cholangitis, progressive familial intrahepatic cholestasis, and Alagille syndrome. The background identifies cholestasis and intrahepatic cholestatic diseases and discusses alkaline phosphatase (ALP) and gamma-glutamyl transpeptidase (GGT) as cholestasis markers.
The document characterizes seladelpar as an orally active PPARδ agonist and describes clinical and prior evidence in which seladelpar is associated with reductions in ALP and GGT. It argues that lowering ALP and/or GGT provides anti-cholestatic treatment for intrahepatic cholestatic diseases, including the diseases listed in the background.
The claimed approach includes administering seladelpar or a salt thereof with specified daily dose levels, with the dose calculated as seladelpar. The disclosure further includes general definitions related to treating, preventing, inhibiting, and relieving, and discusses oral administration and dosing range considerations for seladelpar. The section begins an Example 1 (PBC trial) including inclusion criteria and ALP-based endpoints, and reports reversible transaminase increases.
Claims Coverage
The document contains two independent claims covering methods of treating intrahepatic cholestatic disease with seladelpar (or a salt thereof) at specified daily dose levels (5 mg and 10 mg, respectively, where the dose is calculated as seladelpar). Each independent claim is further refined by dependent claim features including specific salt form, oral administration, and once-per-day dosing.
Treating intrahepatic cholestatic disease with 5 mg seladelpar (dose calculated as seladelpar)
A method of treating an intrahepatic cholestatic disease 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 intrahepatic cholestatic disease with 10 mg seladelpar (dose calculated as seladelpar)
A method of treating an intrahepatic cholestatic disease 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.
Across the independent claims, the inventive coverage centers on treating intrahepatic cholestatic disease with seladelpar (or a salt thereof) at defined daily dose levels calculated as seladelpar (5 mg or 10 mg), with further refinements in dependent claims specifying particular salt form, oral administration, and once-per-day dosing.
Stated Advantages
Lowering ALP and/or GGT for anti-cholestatic treatment.
Reversible transaminase increases are reported in the clinical example.
Documented Applications
Treating primary biliary cholangitis (PBC) in an Example 1 (PBC trial) using ALP-based endpoints and reporting ALP responder rates.
Treating intrahepatic cholestatic diseases including primary biliary cholangitis, primary sclerosing cholangitis, progressive familial intrahepatic cholestasis, and Alagille syndrome.
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