US 12,350,320 B2
Compositions comprising pharmaceutically acceptable salts of glucagon-like peptide-1 analogs and pharmaceutically acceptable salts of amylin analogs, and uses thereof
Tyler Brown, Cambridge, MA (US); and Kelly Ibsen, Boston, MA (US)
Assigned to I2O THERAPEUTICS, INC., Cambridge, MA (US)
Filed by i2O Therapeutics, Inc., Cambridge, MA (US)
Filed on Feb. 16, 2024, as Appl. No. 18/444,501.
Application 18/444,501 is a continuation of application No. PCT/US2022/049585, filed on Nov. 10, 2022.
Claims priority of provisional application 63/295,197, filed on Dec. 30, 2021.
Claims priority of provisional application 63/380,125, filed on Oct. 19, 2022.
Claims priority of provisional application 63/334,410, filed on Apr. 25, 2022.
Claims priority of provisional application 63/277,878, filed on Nov. 10, 2021.
Prior Publication US 2024/0336668 A1, Oct. 10, 2024
Int. Cl. A61K 38/26 (2006.01); A61K 9/08 (2006.01); A61K 31/14 (2006.01); A61K 38/22 (2006.01); A61K 47/12 (2006.01); A61K 47/18 (2017.01); A61K 47/54 (2017.01); A61K 47/68 (2017.01); C07K 14/575 (2006.01); C07K 14/605 (2006.01); C07K 16/24 (2006.01); A61K 38/00 (2006.01)
CPC A61K 38/26 (2013.01) [A61K 9/08 (2013.01); A61K 31/14 (2013.01); A61K 38/22 (2013.01); A61K 47/12 (2013.01); A61K 47/18 (2013.01); A61K 47/183 (2013.01); A61K 47/186 (2013.01); A61K 47/542 (2017.08); A61K 47/6845 (2017.08); C07K 14/575 (2013.01); C07K 14/605 (2013.01); C07K 16/241 (2013.01); A61K 38/00 (2013.01); C07K 2317/24 (2013.01)] 30 Claims
 
1. A composition comprising:
(i) a first compound having the structure of first Formula Ia:

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wherein

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 is a first therapeutic agent having the following configuration: wherein [diacid]-[linker]-[an amylin analog];
wherein the amylin analog has the amino acid sequence of KCNTATCATQRLANFLVHSSNNFGPILPPTNVGSNTY-amide (SEQ ID NO: 20), with a first proviso that the amino acid sequence comprises one or more of the following amino acid substitutions: N14E, V17R, Y37P, F15E, L16E, V17E, or any combination thereof; and
wherein the first compound has a

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 molar ratio of from about 1:1 to about 1:3; and
(ii) an additional agent, wherein the additional agent is a second compound having the structure of second Formula Ia:

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wherein

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 is a second therapeutic agent;
wherein the second therapeutic agent has the sequence of SEQ ID NO: 35; and
wherein the second compound has a

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 molar ratio of from about 1:1 to about 1:7.