VANCOUVER, BRITISH COLUMBIA--(Marketwired - Dec. 17, 2013) - Aquinox Pharmaceuticals Inc. announced today that it has begun dosing patients in a Phase 2 clinical trial of its lead clinical candidate, AQX-1125, a SHIP1 activator, for the treatment of exacerbations of chronic obstructive pulmonary disease (COPD). The multinational trial, known as the FLAGSHIP trial, is being conducted at outpatient clinics across Northern and Central Europe evaluating the safety and efficacy of AQX-1125 in approximately 350-400 unstable moderate to severe COPD patients with a history of frequent exacerbations. The Company has received regulatory approval for the trial in four countries and anticipates completion with top-line results occurring before the end of 2014.
"COPD currently affects up to an estimated 600 million people worldwide with estimates of the number of people suffering from the moderate and severe forms that most frequently require treatment ranging from 65 million to over 200 million. It is estimated that over 20% of patients die within one year of a hospital-treated severe exacerbation and as much as 66% die within three years," stated Mr. David Main, President and CEO of Aquinox. "Since exacerbations involve airway inflammation, treatment with potent anti-inflammatories that reduce the recruitment of immune cells to the lungs is potentially a promising strategy to reduce 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. A third of all COPD patients experience clinically significant acute exacerbations - or "lung attacks" - often triggered by the flu or the common cold, that cause severe shortness of breath, increased mucus and persistent cough. An exacerbation can be so severe it leads to respiratory failure. COPD is the third leading cause of death in the US, the fourth leading cause of death worldwide, and is a leading cause of urgent hospitalization in developed countries. COPD affects almost 25 million people in the US alone at an estimated annual cost of $50 billion.
Most marketed therapies for COPD are inhaled drugs directed towards managing symptoms by dilating narrowed airways (bronchodilators), often in combination with inhaled corticosteroids. These inhaled therapies, while demonstrating the ability to ease breathing, have modest effects on slowing the progression of COPD or reducing exacerbations. The most widely prescribed treatment for an acute exacerbation is a combination of antibiotics and oral corticosteroids but they can only be used for short duration leaving patients susceptible to secondary exacerbations. Consequently, we believe there is a need to identify new anti-inflammatory agents with reduced side effects that can be used for longer duration to resolve and prevent exacerbations.
"We believe COPD as a clinical indication matches well with AQX-1125's demonstrated ability, in both preclinical studies and clinical trials, to reduce inflammation in the airways in response to environmental inflammatory stimuli," said Dr. Stephen Shrewsbury, Senior Vice President, Clinical Development and Chief Medical Officer of Aquinox. "The FLAGSHIP trial has been designed to target COPD patients in greatest need and that could benefit from oral anti-inflammatory therapy to improve recovery from an exacerbation and to prevent subsequent ones."
About Chronic Obstructive Pulmonary Disease (COPD)
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 estimates of the number of people suffering from the moderate and severe forms that most frequently require treatment ranging from 65 million to over 200 million. It is the third leading cause of death in the US and the fourth leading cause of death worldwide. COPD affects almost 25 million people in the US alone at an estimated annual cost of $50 billion.
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 350-400 unstable patients with moderate to severe COPD. This trial focuses on COPD patients with a history of frequent exacerbations, a population with frequent clinical symptoms that we believe will allow us to detect the effects of AQX-1125 in a 13-week trial. 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, a patient-reported outcome tool that measures symptoms.
For more information on the FLAGSHIP study, please visit www.clinicaltrials.gov.
About Aquinox Pharmaceuticals
Aquinox Pharmaceuticals Inc. is a clinical stage pharmaceutical company discovering and developing novel, small molecule therapeutics targeting SH2-containing inositol-5'-phosphatase 1 ("SHIP1") for the treatment of inflammatory disease and cancer. The Company's lead clinical candidate, AQX-1125, is a small molecule activator of SHIP1 potentially suitable for oral once daily dosing. Aquinox has successfully completed one three-part Phase 1 and two Phase 2a clinical trials for AQX-1125 and has now commenced two Phase 2 clinical trials in 2013. The Company has a broad intellectual property portfolio and pipeline of preclinical drug candidates that activate SHIP1. For more information, please visit www.aqxpharma.com.