Aquinox' COPD drug AQX-1125 fails in mid-stage study

Clinical-stage US drug developer Aquinox Pharmaceuticals (Nasdaq: AQXP) has announced disappointing results from its Phase II FLAGSHIP clinical trial with AQX-1125, which failed to demonstrate efficacy in chronic obstructive pulmonary disease (COPD) patients with a history of frequent exacerbations, sending the company’s shares down 8.9% to $1.94.

"We believe that FLAGSHIP was a robust and well conducted trial and the results are conclusive," said David Main, president and chief executive at Aquinox. "Given the encouraging activity seen in our recent LEADERSHIP trial our focus will be on the further development of AQX-1125 in bladder pain syndrome/interstitial cystitis. In addition, we are awaiting results from our KINSHIP trial in atopic dermatitis," he noted.

In the FLAGSHIP trial, patients treated with 200mg oral, once daily AQX-1125 for 12 weeks demonstrated no difference in COPD symptoms compared to placebo, as measured by EXACT, a patient-reported outcome tool. On the secondary endpoint of medically treated exacerbations there was also no benefit observed with AQX-1125. Consistent with past results, the FLAGSHIP trial demonstrated AQX-1125 to be well tolerated. The overall adverse event rate was similar between AQX-1125 and placebo.