Dosing regimen for treating inflammatory bowel disease
Inventors
Harwin, Peter Evan • Kiselak, Tomas • Shaheen, Hussam Hisham • ZHU, Eric Franklin
Assignees
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Publication Number
US-12304956-B1
Publication Date
2025-05-20
Expiration Date
Abstract
Provided herein are variant α4β7 integrin antibodies and methods of use.
Core Innovation
The patent describes a dosing regimen for treating gastrointestinal inflammatory disease in a subject in need thereof using a long acting IL-27 targeting molecule. The regimen uses a two-stage dosing approach in which a first pharmaceutical formulation is administered, followed at least two weeks later by a second pharmaceutical formulation, and thereafter includes maintenance dosing at least four weeks after administration of the second pharmaceutical formulation.
The long acting IL-27 targeting molecule comprises a heavy chain consisting of an amino acid sequence according to SEQ ID NO: 1 and a light chain consisting of an amino acid sequence according to SEQ ID NO: 3. The pharmaceutical formulation is further constrained by a concentration of from about 150 mg/ml to about 200 mg/ml of the long acting IL-27 targeting molecule and by a citrate-free formulation in at least one of the first pharmaceutical formulation and the second pharmaceutical formulation.
The content also ties the regimen to long acting exposure and sustained treatment, including subcutaneous administration of the dosing stages described. The patent content further states dosing concepts using induction versus maintenance regimens with extended dosing intervals, serum/plasma exposure targets, and characterization of long-acting anti-IL27 binding antibodies using engineered heavy/light chains.
Claims Coverage
The partial content includes two independent claims that cover dosing regimens for gastrointestinal inflammatory disease using a long acting IL-27 targeting molecule with specified heavy-chain and light-chain sequences, and with defined two-stage timing and formulation constraints. Across the independent claims, the inventive framework includes timing limitations, dosage amount ranges, citrate exclusion, concentration ranges, and subcutaneous administration for both stages.
Two-stage long acting IL-27 subcutaneous dosing regimen for gastrointestinal inflammatory disease
A dosing regimen for use in treating gastrointestinal inflammatory disease in a subject in need thereof, comprising a first pharmaceutical formulation and a second pharmaceutical formulation administered at least two weeks later, with maintenance dosing at least four weeks after administration of the second pharmaceutical formulation.
Defined IL-27 targeting molecule sequence (SEQ ID NO: 1 / SEQ ID NO: 3)
The long acting IL-27 targeting molecule comprises a heavy chain consisting of an amino acid sequence according to SEQ ID NO: 1 and a light chain consisting of an amino acid sequence according to SEQ ID NO: 3.
Dose amounts and timing across induction and maintenance formulations
The regimen specifies dosage amount ranges for the first pharmaceutical formulation and the second pharmaceutical formulation, and requires administration of the second formulation at least two weeks after the first and maintenance dosing at least four weeks after administration of the second.
Citrate-free formulation and specified concentration range
At least one of the first pharmaceutical formulation and the second pharmaceutical formulation comprises from about 150 mg/ml to about 200 mg/ml of the long acting IL-27 targeting molecule and does not contain citrate.
Both independent claims use the same defined long acting IL-27 targeting molecule (heavy chain SEQ ID NO: 1 and light chain SEQ ID NO: 3) and require a two-stage regimen with the second formulation given at least two weeks after the first and maintenance at least four weeks after the second. The claims also require a citrate-free formulation constraint and specify a concentration range of the IL-27 targeting molecule in at least one of the formulations.
Stated Advantages
Provides a dosing regimen resulting in treatment of gastrointestinal inflammatory disease.
Documented Applications
Treating gastrointestinal inflammatory disease in a subject in need thereof using a long acting IL-27 targeting molecule dosing regimen.
The document describes multidose treatment regimens for inflammatory bowel disease, including Crohn's disease and ulcerative colitis.
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