Compositions for treatment of disorders
Inventors
Bannister, Karen • LASHMAR, Ulla • Pettit, Daniel • Sandal, Thomas
Assignees
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Publication Number
US-12134643-B2
Publication Date
2024-11-05
Expiration Date
Abstract
The invention relates to stable and non-aggregating compositions comprising an IL-17A binding molecule, in particular a single domain antibody. Such compositions are useful for topical administration in the treatment of disease, for example skin disease or asthma.
Core Innovation
Stable, non-aggregating IL-17A binding compositions are described that include at least one single variable heavy-chain (V_H) domain antibody capable of binding human IL-17A. The single V_H domain antibody comprises a CDR1 having SEQ ID NO: 2, a CDR2 having SEQ ID NO: 3, and a CDR3 having SEQ ID NO: 4, and is exemplified by specific V_H domain embodiments such as SEQ ID NO: 1 and SEQ ID NO: 74.
The formulations are defined by Tris/glycine, L-arginine/glutamic acid, and propylene glycol, with optional sorbitol, and the composition pH is about 5 to about 9. In particular embodiments, Tris/glycine is present at about 10-150 mM, L-arginine/glutamic acid is present at about 0.1-150 mM, propylene glycol is present at about 0.1-30%, and sorbitol is optionally present at about 0.1-15%.
The document describes formulation formats including liquid forms and freeze-dried or spray-dried formats that are reconstituted to provide the IL-17A binding composition. It also describes stability and aggregation assessment using analytical methods such as size exclusion chromatography, SDS-PAGE, and other binding/biophysical assays, together with performance assessment in topical/skin-relevant contexts using in vitro psoriatic tissue models and biomarker inhibition and penetration-related studies.
Claims Coverage
The partial content provides one independent claim (clm-00001) defining a specific IL-17A binding composition. The claim includes five inventive features centered on the antibody CDR sequence definition and a defined pH and excipient composition for formulation stability and topical use.
Single variable heavy-chain domain antibody binding human IL-17A by specified CDR1/2/3
A single variable heavy-chain (V_H) domain antibody capable of binding human IL-17A, wherein the antibody comprises a CDR1 having SEQ ID NO: 2, a CDR2 having SEQ ID NO: 3, and a CDR3 having SEQ ID NO: 4.
Tris/glycine formulation component at 10-150 mM
A composition comprising 10-150 mM Tris/glycine.
L-arginine/glutamic acid formulation component at 0.1-150 mM
A composition comprising 0.1-150 mM L-arginine/glutamic acid.
Propylene glycol formulation component at 0.1-30%
A composition comprising 0.1-30% propylene glycol, optionally 0.1-15% sorbitol.
Composition pH about 5 to about 9
Wherein the pH of the composition is about 5 to about 9.
Independent claim clm-00001 is directed to an IL-17A binding composition combining a single V_H domain antibody with specified CDR1/2/3 sequence IDs and a defined Tris/glycine/L-arginine/glutamic acid/propylene glycol formulation system at a pH of about 5 to about 9, optionally including sorbitol.
Stated Advantages
Stable, non-aggregating IL-17A binding compositions.
Documented Applications
Topical delivery for treating IL-17A-mediated diseases, including psoriasis and asthma.
Topical delivery for at least one skin/autoimmune condition including psoriasis and atopic dermatitis.
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