VANCOUVER, British Columbia, June 2, 2014 (GLOBE NEWSWIRE) -- Aquinox Pharmaceuticals, Inc. (Nasdaq:AQXP), a clinical-stage pharmaceutical company discovering and developing targeted therapeutics for inflammatory disease and cancer, today announced expansion of its ongoing Phase 2 clinical trials with its lead product candidate, AQX-1125.
The U.S. Food and Drug Administration (FDA) has accepted Aquinox's Investigational New Drug (IND) application for the Phase 2 LEADERSHIP trial, which is investigating the safety and efficacy of AQX-1125 in reducing pain and urinary symptoms in patients with bladder pain syndrome/interstitial cystitis (BPS/IC). The LEADERSHIP trial has been enrolling patients at clinical sites across Canada and is now active at sites in the United States.
"The United States is an integral part of our development and commercialization plan for AQX-1125," said David J. Main, President and Chief Executive Officer of Aquinox. "Expanding LEADERSHIP into the U.S. provided Aquinox with an important opportunity for the FDA to review our program while also broadening our access to patients for enrollment and engaging with leading U.S. clinicians."
In addition, Aquinox announced that it is expanding its Phase 2 FLAGSHIP trial investigating the safety and efficacy of AQX-1125 in the treatment of exacerbations of chronic obstructive pulmonary disease (COPD) after having obtained regulatory clearance in Australia, where it is currently adding clinical sites. Aquinox is also seeking regulatory clearance to add clinical sites in New Zealand. FLAGSHIP has been enrolling patients at clinical sites across Northern and Central Europe.
"Australia and New Zealand have COPD prevalence and treatment practices that are similar to the countries where the FLAGSHIP trial is already underway and the added sites have contributed significantly to prior drug trials in COPD," said Dr. Stephen Shrewsbury, Senior Vice President, Clinical Development and Chief Medical Officer of Aquinox. "Opening sites in the Southern Hemisphere will allow us to capitalize upon their winter season when patients typically experience an increase in COPD exacerbations."
About Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC)
BPS/IC is a chronic inflammatory bladder disease characterized by pelvic pain and increased urinary urgency and/or frequency. For many sufferers, these symptoms are severe and adversely affect all major aspects of their lives, including overall physical and emotional health, employment, social and intimate relationships, and leisure activities. While the cause of the disease remains largely unknown, erosion of the bladder lining is thought to be a significant contributor. BPS/IC currently affects an estimated 14 million people in the United States. Most BPS/IC patients continue to suffer this debilitating condition, despite treatment with existing therapies. Most current therapies and those in development are focused solely on symptomatic relief of BPS/IC. New and innovative therapies that target the underlying disease processes to reduce the chronic pain and urinary symptoms are needed.
About the LEADERSHIP Trial
The LEADERSHIP trial is a double-blind, placebo-controlled, Phase 2 clinical trial investigating AQX-1125's ability to reduce pain and urinary symptoms in approximately 70 female patients with BPS/IC. The primary objective is to measure the difference in the change from baseline in the mean daily bladder pain score based on an 11-point numeric rating scale (NRS) at six weeks recorded by eDiary. For more information on the LEADERSHIP trial, please visit www.clinicaltrials.gov.
About Chronic Obstructive Pulmonary Disease (COPD) & Related Exacerbations.
COPD is a lung disease frequently associated with cigarette smoking and air pollution and is characterized by progressive loss of lung function and chronic inflammation of the airways. COPD currently affects up to an estimated 600 million people worldwide, with up to 200 million suffering from the moderate and severe forms that most frequently require treatment. It is the third leading cause of death in the United States and the fourth leading cause of death worldwide. In the United States alone, the annual economic burden of treating COPD is estimated at $50 billion. COPD patients suffer periodic episodes with severe worsening of symptoms, known as exacerbations. Of COPD patients, 22-40% die within one year of a severe exacerbation and 66% die within three years. Since exacerbations involve severe increased airway inflammation, treatment with potent anti-inflammatories is a potentially promising strategy to reduce exacerbations.
About the FLAGSHIP Trial
The FLAGSHIP trial is a multinational, double-blind, placebo-controlled, Phase 2 clinical trial investigating AQX-1125's ability to reduce the effects of exacerbations in approximately 400 unstable patients with moderate to severe COPD. The primary endpoint is the change in the severity, duration and reoccurrence of exacerbations in patients treated with AQX-1125 versus placebo, as measured by EXACT-PRO, a patient-reported outcome tool that measures symptoms. For more information on the FLAGSHIP trial, please visit www.clinicaltrials.gov.
About Aquinox Pharmaceuticals
Aquinox Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company discovering and developing novel drug candidates to treat inflammation and cancer. Aquinox's primary focus is advancing anti-inflammatory product candidates targeting SHIP1, a key regulator of the PI3K immune cell-signaling pathway. Aquinox's lead product candidate, AQX-1125, is a SHIP1 activator that has demonstrated broad anti-inflammatory properties and has successfully completed three clinical trials with over 100 subjects dosed with once daily oral therapy. Aquinox is currently investigating AQX-1125 in two Phase 2 trials for chronic obstructive pulmonary disease (COPD) exacerbations and bladder pain syndrome/interstitial cystitis (BPS/IC), both debilitating chronic inflammatory diseases affecting millions of people worldwide. For more information please visit www.aqxpharma.com.
Cautionary Note on Forward-looking Statements
Certain of the statements made in this press release are forward looking, such as those, among others, relating to: the success and timing of our Phase 2 clinical trials; the outcome of our interactions with the FDA and other regulatory authorities; and potential market opportunities for AQXP-1125. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: our ability to enroll patients in our clinical trials at the pace that we project; the size and growth of the potential markets for AQX-1125 or any future product candidates and our ability to serve those markets; our ability to obtain and maintain regulatory approval of AQX-1125 or any future product candidates; and our expectations regarding the potential safety, efficacy or clinical utility of AQX-1125 or any future product candidates. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. More information about the risks and uncertainties faced by Aquinox is contained in the company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2014 filed with the Securities and Exchange Commission. Aquinox disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.