Compositions comprising pharmaceutically acceptable salts of glucagon-like peptide-1 analogs and uses thereof
Inventors
Assignees
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Publication Number
US-12233111-B2
Publication Date
2025-02-25
Expiration Date
Abstract
Provided herein are compounds having the structure of Formula Ia, wherein the compounds comprise a therapeutic agent having the sequence of SEQ ID NO: 35, and the compounds have an anion:cation molar ratio of from about 1:1 to about 1:7, and methods of using thereof for the treatment of metabolic diseases or disorders, including type 1 diabetes, type 2 diabetes, obesity, overweight, and nonalcoholic steatohepatitis, and for reducing weight in a subject in need thereof.
Core Innovation
The invention relates to therapeutic compounds having the structure of Formula Ia and related Formula II/IIa/IIb/IIc structural variants, where the therapeutic agent has the sequence of SEQ ID NO: 35. The compounds include two components present in a molar ratio of from about 1:1 to about 1:7, with defined cationic nitrogen-containing moieties, choline or choline derivative cation moieties, and anions or diacids.
The disclosure further includes dual GIP/GLP-1 receptor agonist-containing compounds, amylin analogs, GLP-1 analogs such as liraglutide and exenatide, and antibodies. It also describes Formula-based therapeutic-agent ionic or complex structures defined by Formula I, Formula II, Formula III, Formula Ia, Formula IIc, and related linker variants, including gammaGlu and OEG linkers and C18 or C20 diacid residues.
The compounds and compositions are described as ionic liquids or pharmaceutical compositions with specified molar ratios depending on the embodiment. The described compounds and compositions are presented for use in metabolic disease and disorder treatment, autoimmune or immunological disorders, and weight management, with administration routes including subcutaneous, intravenous, and oral.
Claims Coverage
The consolidated claim coverage includes 2 independent claims. The inventive features center on a Formula Ia compound having a therapeutic agent with the sequence of SEQ ID NO: 35 and a specified molar ratio range, and a second independent compound defined by a specified structure not provided in the excerpt; dependent claims further refine therapeutic use, disease targets, and administration routes.
Formula Ia therapeutic compound with SEQ ID NO: 35 and molar ratio of about 1:1 to about 1:7
A compound having the structure of Formula Ia, wherein the therapeutic agent has the sequence of SEQ ID NO: 35, and wherein the compound has a molar ratio of from about 1:1 to about 1:7.
Specified-structure compound for therapeutic use
A compound having the following structure, as recited in the independent claim; the structure is not provided in the excerpt.
Overall, the claims cover a Formula Ia compound defined by SEQ ID NO: 35 and a molar ratio constraint, together with a second independently defined compound structure. Dependent coverage links these compounds to treatment of metabolic diseases or disorders, named conditions including type 1 diabetes, type 2 diabetes, obesity, overweight, and nonalcoholic steatohepatitis (NASH), and administration routes including subcutaneous, intravenous, and oral, with an alternative weight-reduction objective.
Stated Advantages
Increased solubility of the therapeutic agent versus a formulation without the ionic liquid.
Enhanced delivery efficiency of the therapeutic agent versus a formulation without the ionic liquid.
Documented Applications
Treatment of metabolic diseases and disorders, including type 1 diabetes mellitus, type 2 diabetes mellitus, obesity, overweight, and nonalcoholic steatohepatitis (NASH).
Weight management and weight reduction in a subject by administration of a therapeutically effective amount of the compound.
Treatment of autoimmune and immunological disorders including Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, Behçet’s disease, hidradenitis suppurativa, uveitis, juvenile idiopathic arthritis, multiple sclerosis, and eosinophilic esophagitis.
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