COMPOSITIONS OF THYMIC STROMAL LYMPHOPOIETIN-BINDING FRAGMENTS (TSLP) AND METHODS OF USE THEREOF

Claims

This disclosure relates to pharmaceutical compositions comprising antigen-binding fragments specific for thymic stromal lymphopoietin (TSLP) suitable for inhalation, and to a process for preparing an inhalation pharmaceutical composition comprising such a TSLP-specific antigen-binding fragment. This disclosure further relates to methods for treating TSLP-related conditions, such as asthma and COPD, using the pharmaceutical compositions. The pharmaceutical compositions include a mixture of leucine, trileucine, and histidine that results in a formulation suitable for delivering antigen-binding fragments derived from anti-TSLP antibodies by inhalation.

1. A pharmaceutical composition comprising spray-dried particles, wherein the spray-dried particles comprise: a. approximately 5% (w / w) to approximately 15% (w / w) of leucine; b. approximately 1% (w / w) to approximately 5% (w / w) of trileucine; c. approximately 1% (w / w) to approximately 10% (w / w) of histidine buffer at a pH of between approximately pH 5 and pH 6; d. approximately 1% (w / w) and approximately 80% (w / w) of an antigen-binding fragment of an anti-thymic stromal lymphopoietin (TSLP) antibody; and e. a glass-stabilizing agent.

3. The pharmaceutical composition according to claim 2, comprising approximately 2% (w / w) of trileucine.

37. A dry powder formulation obtained by the process of any of claims 33 to 36.

83. A pharmaceutical composition for use in a method for treating asthma in a subject in need, wherein the pharmaceutical composition comprises a dose of approximately 0.4 mg to approximately 8 mg of an antigen-binding fragment of an anti-TSLP antibody to be administered to the subject once daily (Q1D) by inhalation.