Aquinox Pharma (AQXP) Commences Dosing in AQX-1125 PHase 3 as IC/BPS Treatment
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Aquinox Pharmaceuticals, Inc. (Nasdaq: AQXP) announced that it has initiated dosing in a Phase 3 clinical trial of AQX-1125 for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS).
The LEADERSHIP 301 trial will enroll a minimum of 300 female patients and up to 300 male subjects at clinical research centers in Canada, the United States and Europe and will be conducted as a three arm, multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical trial investigating the ability of 200 mg and 100 mg oral, once daily AQX-1125 to reduce bladder pain in patients with moderate to severe IC/BPS.
“Building upon the positive results from the LEADERSHIP Phase 2 trial where AQX-1125 demonstrated an ability to improve both pain and urinary symptoms in patients with IC/BPS, we are excited to begin this next phase of development towards potential commercialization.” said David Main, President & CEO of Aquinox. “We are eager to continue to explore the potential of AQX-1125 to meet this unmet medical need, as it is a severely debilitating disease where no new oral therapy has been approved in the last twenty years.”
The primary endpoint of the LEADERSHIP 301 trial will be to measure the difference in the change from baseline in the maximum daily bladder pain score based on an 11-point numeric rating scale (NRS) at twelve weeks recorded by electronic diary. The trial will also include an open-label extension of up to 40 weeks affording all participating patients the opportunity for treatment with AQX-1125. Secondary endpoints will include urinary symptoms, including frequency and nighttime awakenings, as well as measures of quality of life. Top-line data from the LEADERSHIP 301 trial is anticipated in the fourth quarter of 2017. For more information on the LEADERSHIP 301 trial, please visit www.clinicaltrials.gov.
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