Efficacy and Safety of AQX-1125 in Unstable COPD

Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of morbidity and mortality worldwide. Acute exacerbations of COPD are usually treated with steroids and/or antibiotics. Currently this conventional therapy has significant side effects including osteoporosis, cataracts and suppression of the immune system (from the steroids) and increasing bacterial resistance and other side effects from the use of antibiotics. During an acute exacerbation of COPD, the inflammation in the airways increases.

AQX-1125 represents a new type drug that based current data is thought decrease the inflammatory process and therefore may provide a therapeutic benefit in the treatment of COPD.

Inclusion criteria

• Male or female aged ≥40 years at screening
• History of COPD for at least 18 months prior to screening, characterised by excessive sputum production
• 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
• At least 2 documented exacerbations during the last 18 months prior to screening.
• 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
• 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.
• Former smoker or current smoker, both with a smoking history of at least 10 pack years

Exclusion criteria

• Diagnosis of other relevant lung disease (e.g. asthma, cystic fibrosis [CF] or significant non-CF bronchiectasis)
• Known alpha-1-antitrypsin deficiency
• Treatment with roflumilast or theophylline within 1 month prior to screening
• 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
• Hospitalisation for more than 7 days for current acute exacerbation, or the requirement for intubation during hospitalisation
• For outpatients, prior medical history indicating that previous exacerbations required >3 weeks to stabilise