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Publication Number
US-11406611-B2
Publication Date
2022-08-09
Expiration Date
Abstract
Treatment of intrahepatic cholestatic diseases by therapy with MBX-8025 or an MBX-8025 salt.
Core Innovation
The invention relates to a method of treating an intrahepatic cholestatic disease by administering to a subject in need thereof a therapeutically effective amount of (R)-2-(4-((2-ethoxy-3-(4-(trifluoromethyl)phenoxy)propyl)thio)-2-methylphenoxy)acetic acid or a salt thereof. The disclosed compound is presented as an orally active PPAR6 agonist, including MBX-8025 and MBX-8025 salts such as L-lysine dihydrate salt. The method is positioned for treating intrahepatic cholestatic diseases such as PBC, PSC, PFIC, and Alagille syndrome.
The problem addressed is intrahepatic cholestatic disease, for which the patent describes cholestasis and the lowering of cholestasis biomarkers. The disclosed rationale states that MBX-8025 lowers cholestasis biomarkers ALP and GGT. This biomarker improvement is used to support the therapeutic effect of administering the specified (R)-compound or its salt.
The disclosure also summarizes prior art relating to MBX-8025 and its metabolic and lipid effects. Within the provided description context, the invention frames the treatment as oral administration of MBX-8025 (or salts) at therapeutically effective amounts in adults, aiming for improvements in ALP and GGT.
Claims Coverage
The document provides two independent claims covering treatment of an intrahepatic cholestatic disease using closely defined (R)-2-(4-((2-ethoxy-3-(4-(trifluoromethyl)phenoxy)propyl)thio)-2-methylphenoxy)acetic acid, either generally as a salt or specifically as the L-lysine dihydrate salt. The independent claims emphasize administering a therapeutically effective amount.
Treating an intrahepatic cholestatic disease with the (R)-compound or a salt
Administering to a subject in need thereof a therapeutically effective amount of (R)-2-(4-((2-ethoxy-3-(4-(trifluoromethyl)phenoxy)propyl)thio)-2-methylphenoxy)acetic acid or a salt thereof.
Treating an intrahepatic cholestatic disease with the (R)-compound L-lysine dihydrate salt
Orally administering to a subject in need thereof a therapeutically effective amount of (R)-2-(4-((2-ethoxy-3-(4-(trifluoromethyl)phenoxy)propyl)thio)-2-methylphenoxy)acetic acid L-lysine dihydrate salt.
Collectively, the claims cover oral treatment of intrahepatic cholestatic disease using a therapeutically effective amount of the specified (R)-2-(4-((2-ethoxy-3-(4-(trifluoromethyl)phenoxy)propyl)thio)-2-methylphenoxy)acetic acid, either as the compound or as a salt, including the L-lysine dihydrate salt.
Stated Advantages
Lowers cholestasis biomarkers ALP and GGT.
Documented Applications
Treatment of intrahepatic cholestatic diseases including PBC, PSC, PFIC, and Alagille syndrome.
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