US 12,257,229 B2
Peptide pharmaceuticals for treatment of NASH and other disorders
John J Nestor, Sugar Land, TX (US)
Assigned to Spitfire Pharma LLC, Gaithersburg, MD (US)
Filed by Mederis Diabetes LLC, Sugar Land, TX (US)
Filed on Dec. 20, 2022, as Appl. No. 18/068,788.
Application 18/068,788 is a continuation of application No. 16/958,597, granted, now 11,541,028, previously published as PCT/US2019/012194, filed on Jan. 3, 2019.
Claims priority of provisional application 62/613,396, filed on Jan. 3, 2018.
Prior Publication US 2023/0218564 A1, Jul. 13, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/351 (2006.01); A61K 38/26 (2006.01); A61P 1/16 (2006.01); A61P 13/12 (2006.01); A61K 9/00 (2006.01); A61K 45/06 (2006.01); A61K 47/54 (2017.01)
CPC A61K 31/351 (2013.01) [A61K 38/26 (2013.01); A61P 1/16 (2018.01); A61P 13/12 (2018.01); A61K 9/0019 (2013.01); A61K 45/06 (2013.01); A61K 47/543 (2017.08); A61K 47/549 (2017.08)] 15 Claims
 
1. A method of treating a fatty liver disease, comprising administering a pharmaceutical composition or a pharmaceutically acceptable salt thereof, to a subject in need thereof, wherein the comprising comprises:
a) SEQ. ID. NO. 1110; and,
b) a pharmaceutically acceptable diluent or buffer;
and wherein the fatty liver disease is non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH) and SEQ ID NO: 1110 is according to Formula III-A aa1-aa2-aa3-aa4-aa5-aa6-aa7-aa8-aa9-aa10-aa11-aa12-aa13-aa14-aa15-aa16-aa17-aa18-aa19-aa20-aa21-aa22-aa23-aa24-aa25-aa26-aa27-aa28-aa29-Z
wherein:
Z is —OH or —NHR3, wherein R3 is H, unsubstituted or substituted C1-C12 alkyl, or a PEG-containing group of less than 10 kDa;
aa1 is His;
aa2 is Aib;
aa3 is Gln;
aa4 is Gly;
aa5 is Thr;
aa6 is Phe;
aa7 is Thr;
aa8 is Ser;
aa9 is Asp;
aa10 is Tyr, Glu, Lys or U(X);
aa11 is Ser;
aa12 is Lys or Glu;
aa13 is Tyr;
aa14 is Leu, Glu or Lys;
aa15 is Asp;
aa16 is Glu or Lys;
aa17 is Gln, Glu or U(X);
aa18 is Ala;
aa19 is Ala;
aa20 is Glu, Lys or U(X);
aa21 is Glu;
aa22 is Phe;
aa23 is Ile;
aa24 is Gln, Glu or U(X);
aa25 is Trp;
aa26 is Leu;
aa27 is Leu;
aa28 is Gln;
aa29 is Thr;
aa10 and aa14, or aa12 and aa16, or aa16 and aa20 are cyclized through their side chains to form a lactam linkage; and
provided that one, or at least one of aa10, aa17, aa20 and aa24 is a natural or unnatural amino acid U covalently attached to an alkyl glycoside (X).