Aquinox Pharmaceuticals Updates FLAGSHIP COPD Trial Status

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by Isaura Santos |

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Therabron program for respiratory diseases based on novel isoforms of its lead product

The ACI Association recently compiled a report on Aquinox Pharmaceuticals Inc. based on the company’s internal reports to make them available to the general public. Aquinox is currently developing AQX-1125, an investigational therapy for COPD, which was recently evaluated in a phase 2 clinical trial called FLAGSHIP.

Aquinox announced recently that its FLAGSHIP clinical trial (Phase 2) did not succeed in demonstrating efficacy in treating patients suffering with chronic obstructive pulmonary disease (COPD) with a record of frequent exacerbations. Those that received an oral dose of 200 mg AQX-1125 each day for 12 weeks did not reveal any difference in COPD symptoms in comparison to placebo; these values were measured using a tool called EXACT. In conclusion, no benefits were observed with AQX-1125, however, the secondary endpoint of medically treated exacerbations and AQX-1125 was well tolerated since adverse events were similar between AQX-1125 and placebo.

David Main, President & CEO, noted, “We believe that FLAGSHIP was a robust and well conducted trial and the results are conclusive.” He added, “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.”

The FLAGSHIP trial was initiated in July 2013 and the goal was to evaluate the ability of a 200mg oral dose of AQX-1125 to reduce the effects of exacerbations in those suffering with moderate and severe COPD. The main goal of the study was to modify the duration, severity and recurrence of COPD exacerbations in those treated with AQX-1125 in comparison to those treated with placebo (this was measured by EXACT).

AQX-1125 is a small molecule that activates SHIP1 that, in turn, regulates the PI3K cellular signaling pathway. AQX-1125 increases the SHIP1 activity and speed up a natural mechanism that maintains the immune system’s homeostasis and reduces immune cell activation and migration to inflammated locations. In several pre-clinical and clinical trials AQX-1125 demonstrated favorable drug properties and, additionally, the firm is also assessing AQX-1125 for atopic dermatitis.