Efficacy and Safety of AQX-1125 in Unstable COPD

Inclusion Criteria:

1. Male or female aged ≥40 years at screening

2. History of COPD for at least 18 months prior to screening, characterised by excessive
sputum production

3. Chronic productive cough for at least 3 months in each of the 2 years prior to
screening (if other causes of productive cough have been excluded) and/or an
exacerbation of COPD with predominantly bronchitic symptoms at enrolment

4. At least 2 documented exacerbations during the last 18 months prior to screening.

5. Presentation of a diagnosed acute exacerbation of COPD, or have recently (within 3
days) been discharged from hospital due to an acute exacerbation of COPD

6. Ability to perform pulmonary function testing and with documented fixed airway
obstruction determined by an FEV1 /FVC [forced vital capacity] ratio
(post-bronchodilator) of <0.70 and a predicted FEV1 value of 30%-80% of normal within
the 6 months prior to Visit 1.

7. Former smoker or current smoker, both with a smoking history of at least 10 pack
years

Exclusion Criteria:

1. Diagnosis of other relevant lung disease (e.g. asthma, cystic fibrosis [CF] or
significant non-CF bronchiectasis)

2. Known alpha-1-antitrypsin deficiency

3. Treatment with roflumilast or theophylline within 1 month prior to screening

4. Lobar pneumonia, with current positive chest X-ray (CXR) or within the 3 months prior
to screening including the presence of any new radiological infiltrate on CXR within
the previous two weeks

5. Hospitalisation for more than 7 days for current acute exacerbation, or the
requirement for intubation during hospitalisation

6. For outpatients, prior medical history indicating that previous exacerbations
required >3 weeks to stabilise