Update on a FLAGSHIP Trial - Report on Aquinox Pharmaceuticals

Aug 05, 2015, 09:05 ET from www.aciassociation.com

NEW YORK, August 5, 2015 /PRNewswire/ --

ACI Association has initiated research coverage on Aquinox Pharmaceuticals Inc. (NASDAQ: AQXP). Select highlights from the internally released reports are being made available to the general public (included below), with access to the entirety of the research available to new members.

Today, membership is open to readers on a complementary basis at the following URL: http://www.aciassociation.com/?c=AQXP  

Highlights from our AQXP Report include:

  • Results from the FLAGSHIP Trial - On July 09, 2015, Aquinox Pharmaceuticals Inc. (Aquinox) announced that its Phase 2 FLAGSHIP clinical trial failed to demonstrate efficacy in chronic obstructive pulmonary disease (COPD) patients with a history of frequent exacerbations. The Company said that the patients, who were given an oral dose of 200 mg AQX-1125 for 12 weeks on a daily basis, demonstrated no difference in COPD symptoms compared to placebo, as measured by a patient-reported outcome tool called EXACT. Moreover, no benefits were observed with AQX-1125, on the secondary endpoint of medically treated exacerbations. Though consistent with past results, the FLAGSHIP trial with AQX-1125 was well tolerated, the overall adverse event rate was similar between AQX-1125 and placebo.
  • Management Comments - President & CEO at Aquinox, David Main said, "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."
  • An overview of the FLAGSHIP trial - While elaborating on the details of the FLAGSHIP trial, Aquinox said that this multicenter, randomized (1:1), double-blind, placebo-controlled, Phase 2 clinical trial was initiated in July 2013. It was conducted to examine the ability of 200mg AQX-1125 oral dose of AQX-1125 in reducing the effects of exacerbations in patients with moderate to severe COPD. The primary endpoint of the study was the change in the severity, duration and recurrence of COPD exacerbations in patients treated with AQX-1125 versus placebo, as measured by EXACT.
  • Aquinox's lead drug candidate - AQX-1125 - Aquinox's drug candidate, AQX-1125 is a small molecule activator of SHIP1, a regulating component of the PI3K cellular signaling pathway. AQX-1125 increases SHIP1 activity and accelerates a natural mechanism that has evolved to maintain homeostasis of the immune system and to reduce immune cell activation and migration to sites of inflammation. In various preclinical studies and clinical trials conducted by the Company, AQX-1125 demonstrated preliminary safety and favorable drug properties. Additionally, the Company is also examining AQX-1125 for atopic dermatitis in its ongoing KINSHIP Phase 2 trial and its top-line data is scheduled for release by the first quarter of 2016.

To find out how this influences our rating on Aquinox Pharmaceuticals Inc., read the full report in its entirety here: http://www.aciassociation.com/?c=AQXP


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