Nebulization of monoclonal antibodies for treating pulmonary diseases

Abstract

The present application relates to methods and compositions employing an antibody that inhibits activation of the complement system and can be used to prevent or treat a pulmonary disease or condition.

1 . A method for preventing or treating a pulmonary condition in a subject comprising administering to the subject a therapeutically effective amount of an antibody that inhibits activation of the complement cascade and an additional active agent.  
   
   
       2 . The method of  claim 1 , wherein the pulmonary condition is selected from the group consisting of: asthma, bronchitis, a chronic obstructive pulmonary disease (COPD) interstitial lung diseases, lung malignancies, α-1 anti-trypsin deficiency, emphysema, bronchiectasis, bronchiolitis obliterans, sarcoidosis, pulmonary fibrosis, and collagen vascular disorders.  
   
   
       3 . The method of  claim 1 , wherein the subject is a human.  
   
   
       4 . The method of  claim 1 , wherein the antibody is specific to C5.  
   
   
       5 . The method of  claim 1 , wherein the antibody is specific to C5 convertase.  
   
   
       6 . The method of  claim 1 , wherein the antibody is specific to C5a or C5b-9.  
   
   
       7 . The method of  claim 1 , wherein the antibody is eculizumab or pexelizumab.  
   
   
       8 . The method of  claim 1 , wherein the antibody is selected from the group consisting of: a full length immunoglobulin, a single chain antibody, a domain antibody, a Fab fragment, and an antibody having a Fab fragment and a mutated Fc portion.  
   
   
       9 . The method of  claim 7 , wherein the mutated Fc portion does not activate complement.  
   
   
       10 . The method of  claim 1 , wherein the antibody is administered prior to manifestation of the pulmonary condition, during manifestation of the pulmonary condition, or after manifestation of the pulmonary condition.  
   
   
       11 . The method of  claim 1 , wherein the additional active agent is a corticosteroid.  
   
   
       12 . The method of  claim 1 , wherein the corticosteroid is dexamethasone.  
   
   
       13 . The method of  claim 1 , wherein the antibody and the additional active agent may be administered to the subject by the same delivery method or route.  
   
   
       14 . The method of  claim 1 , wherein the antibody and the additional active agent may be administered to the subject by different delivery methods or routes.  
   
   
       15 . An aerosol composition comprising an antibody that inhibits activation of the complement cascade, wherein the composition is suitable for preventing or treating a pulmonary condition in a subject.  
   
   
       16 . The aerosol composition of  claim 15 , wherein the antibody is formulated in a composition suitable for aerosolization.  
   
   
       17 . The aerosol composition of  claim 15  further comprising an additional active agent.  
   
   
       18 . A biopharmaceutical package comprising: a) an antibody that inhibits activation of the complement cascade; and b) a nebulizer, wherein the package is suitable for preventing or treating a pulmonary condition in a subject.  
   
   
       19 . The biopharmaceutical package of  claim 18 , wherein the nebulizer is selected from the group consisting of a jet air nebulizer, an ultrasonic nebulizer, a vibrating mesh nebulizer and a shockwave nebulizer.  
   
   
       20 . The biopharmaceutical package of  claim 19  further comprising instructions for use.  
   
   
       21 . The biopharmaceutical package of  claim 19  further comprising an additional active agent.  
   
   
       22 . A pulmonary drug delivery kit comprising: a) an inhaler; and b) an antibody formulated for inhalation delivery.  
   
   
       23 . The kit of  claim 22 , wherein said inhaler is a metered dose inhaler.  
   
   
       24 . The kit of  claim 23 , whereon the metered dose inhaler is a pressurized metered dose inhaler.  
   
   
       25 . The kit of any one of claims  22  or  23 , wherein said inhaler further comprises a holding chamber.  
   
   
       26 . The kit of  claim 22 , wherein said inhaler is a nebulizer.  
   
   
       27 . The kit of  claim 26 , wherein said nebulizer is an ultrasonic nebulizer.  
   
   
       28 . The kit of  claim 26 , wherein said nebulizer is a jet air nebulizer.  
   
   
       29 . The kit of  claim 22 , wherein said inhaler is a dry powder inhaler.  
   
   
       30 . A pulmonary drug delivery kit comprising a) an anti C5 antibody composition comprising 1 mg/ml to 200 mg/ml; and b) a label indicating administration by nebulization.