Method of selecting patients for treatment with an il-33 axis antagonist
AssigneeMedImmune, LLC
InventorsIan Christopher SCOTT, Rachel Patricia MOATE
Life of this patent
Estimating the term…
Abstract
The present disclosure relates to a method of treating a subject suffering from respiratory distress or preventing respiratory distress in a subject at risk thereof with an IL-33 axis antagonist, to a method of determining whether such a subject will respond to treatment with an IL-33 axis antagonist, and to a method of selecting a subject for treatment with an IL-33 axis antagonist, by determining whether the level of IL-33/sST2 in a sample obtained from the subject is greater than or equal to a given reference level. Uses corresponding to said methods are also provided.
Claims38
A method of treating a subject suffering from respiratory distress, or preventing respiratory distress in a subject at risk thereof, comprising administering to the subject an effective amount of an anti-IL-33 antibody or antigen binding fragment thereof, wherein the level of IL-33/sST2 in a sample obtained from the subject has been determined to be greater than or equal to a reference level of 25 μg/ml, wherein the anti-IL-33 antibody or antigen binding fragment thereof comprises a heavy chain variable region (VH) having VHCDRs 1-3 of SEQ ID NO:
- 37, SEQ ID NO:
- 38 and SEQ ID NO:
- 39, respectively, and a light chain variable region (VL) having VLCDRs 1-3 of SEQ ID NO:
- 40, SEQ ID NO:
- 41 and SEQ ID NO:
- 42, respectively.
A method of preventing acute respiratory failure in a subject at risk thereof, comprising administering to the subject an effective amount of an anti-IL-33 antibody or antigen binding fragment thereof, wherein the level of IL-33/sST2 in a sample obtained from the subject has been determined to be greater than or equal to a reference level of 25 μg/ml, wherein the anti-IL-33 antibody or antigen binding fragment thereof comprises a heavy chain variable region having VHCDRs 1-3 of SEQ ID NO:
- 37, SEQ ID NO:
- 38 and SEQ ID NO:
- 39, respectively, and a light chain variable region having VLCDRs 1-3 of SEQ ID NO:
- 40, SEQ ID NO:
- 41 and SEQ ID NO:
- 42, respectively.
A method of selecting a subject suffering from respiratory distress, or at risk of suffering from respiratory distress, for treatment with an anti-IL-33 antibody or antigen binding fragment thereof comprising:
- measuring the level of IL-33/sST2 in a sample obtained from the subject;
- and selecting the subject for said treatment if the level of IL-33/sST2 in the sample is greater than or equal to a reference level of 25 μg/ml, wherein the anti-IL-33 antibody or fragment thereof comprises a heavy chain variable region having VHCDRs 1-3 of SEQ ID NO:
- 37, SEQ ID NO:
- 38 and SEQ ID NO:
- 39, respectively, and a light chain variable region having VLCDRs 1-3 of SEQ ID NO:
- 40, SEQ ID NO:
- 41 and SEQ ID NO:
- 42, respectively.
A method of determining whether a subject suffering from respiratory distress, or at risk of suffering from respiratory distress, is likely to respond to treatment with an anti-IL-33 antibody or antigen binding fragment thereof comprising:
- measuring the level of IL-33/sST2 in a sample obtained from the subject;
- and determining that the subject is likely to respond to said treatment if the measured level of IL-33/sST2 in the sample is greater than or equal to a reference level of 25 pg/ml, wherein the anti-IL-33 antibody or fragment thereof comprises a heavy chain variable region having VHCDRs 1-3 of SEQ ID NO:
- 37, SEQ ID NO:
- 38 and SEQ ID NO:
- 39, respectively, and a light chain variable region having VLCDRs 1-3 of SEQ ID NO:
- 40, SEQ ID NO:
- 41 and SEQ ID NO:
- 42, respectively.
The method of any preceding claim wherein the reference level is 26 pg/ml, 27 pg/ml, 28 pg/ml, 29 pg/ml or 30 pg/ml, preferably wherein the reference level is 30.15 pg/ml.
The method of any preceding claim wherein the sample is a whole blood sample, a serum sample, a plasma sample or a combination thereof.
The method of any preceding claim wherein the respiratory distress is acute respiratory failure.
The method of any preceding claim wherein the subject is suffering from COVID-19.
The method of any preceding claim, wherein the subject is suffering from pneumonia, or is suspected from suffering from pneumonia.
The method of any preceding claim, wherein the subject is suffering from viral pneumonia, or is suspected from suffering from viral pneumonia.
The method of any preceding claim, wherein the subject is suffering from, or is at risk of, acute respiratory failure caused by COVID-19 and/or viral pneumonia.
The method of any preceding claim, wherein the subject is suffering from, or is at risk of, type 1 or type 2 acute respiratory failure caused by COVID-19 and/or viral pneumonia.
The method of any preceding claim, wherein the subject has tested positive for SARS-Cov-2 infection.
The method of any preceding claim, wherein the subject has a viral lower respiratory tract infection or disease.
The method according to any preceding claim, wherein the anti-IL-33 antibody or antigen binding fragment thereof comprises a heavy chain variable region (VH) according to SEQ ID NO:1 and a light chain variable region (VL) according to SEQ ID NO.19.
The method according to any preceding claim, wherein the IL-33 axis antagonist is tozorakimab.
The method of any preceding claim wherein the subject requires supplemental oxygen or ventilation.
The method of any preceding claim, wherein the subject is hospitalized.
The method of any preceding claim, wherein the subject has a viral lower respiratory tract infection or disease, is hospitalized and requires supplemental oxygen or ventilation.
A method of reducing the likelihood of death and/or acute respiratory failure in a subject suffering from respiratory distress or at risk of suffering from respiratory distress, comprising administering to the subject an effective amount of an anti-IL-33 antibody or antigen binding fragment thereof, wherein the level of IL-33/sST2 in a sample obtained from the subject has been determined to be greater than or equal to a reference level of 25 μg/ml, wherein the anti-IL-33 antibody or antigen binding fragment thereof comprises a heavy chain variable region having VHCDRs 1-3 of SEQ ID NO:
- 37, SEQ ID NO:
- 38 and SEQ ID NO:
- 39, respectively, and a light chain variable region having VLCDRs 1-3 of SEQ ID NO:
- 40, SEQ ID NO:
- 41 and SEQ ID NO:
- 42, respectively.
Dependencies are inferred from the claim text.