VANCOUVER, Canada I February 2, 2015 I Aquinox Pharmaceuticals, Inc. (“Aquinox”) (AQXP), a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology, today announced that it has reached its target enrollment in the Phase 2 FLAGSHIP trial of AQX-1125 for the treatment of chronic obstructive pulmonary disease (COPD) following a recent exacerbation.
“COPD has emerged as the third leading cause of death in the United States and worldwide in part due to the inability to effectively resolve and prevent exacerbations,” said David Main, President and CEO of Aquinox. “FLAGSHIP was designed to yield comprehensive insight into the effects of oral, once daily AQX-1125 on overall COPD symptoms including the frequency, severity and duration of exacerbations. We would like to thank all of the patients and investigators who participated in FLAGSHIP and we anticipate last patient final visit in May 2015 with reporting of top line data near mid-year.”
The FLAGSHIP trial is a multinational, Phase 2 clinical trial investigating the ability of AQX-1125 to reduce the effects of exacerbations in approximately 400 unstable patients with moderate to severe COPD. The FLAGSHIP trial focuses on COPD patients with a history of frequent exacerbations.
The primary endpoint of the FLAGSHIP trial is the change in the severity, duration and recurrence of symptoms associated with exacerbations in patients treated with AQX-1125 versus placebo, as measured by EXACT, a patient-reported outcome tool. Symptoms most frequently associated with COPD exacerbations include cough, breathlessness, mucus production, chest tightness and difficulty with physical exertion.
About AQX-1125
AQX-1125, Aquinox’s lead drug candidate, is a small molecule activator of SHIP1, which is a regulating component of the PI3K cellular signaling pathway. By increasing SHIP1 activity, AQX-1125 accelerates a natural mechanism that has evolved to maintain homeostasis of the immune system and reduce immune cell activation and migration to sites of inflammation. AQX-1125 has demonstrated preliminary safety and favorable drug properties in multiple preclinical studies and clinical trials. Aquinox is currently exploring AQX-1125 as an oral, once daily treatment in several Phase 2 trials.
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 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 COPD exacerbations. Symptoms most frequently associated with a COPD exacerbation, and measured by EXACT, include cough, breathlessness, mucus production, chest tightness and difficulty with physical exertion. Of COPD patients, 22-40% die within one year of a severe COPD exacerbation and 66% die within three years. Since COPD 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 the ability of AQX-1125 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 recurrence of COPD 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 trial please visit www.clinicaltrials.gov.
About Aquinox Pharmaceuticals, Inc.
Aquinox Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology. Aquinox’s lead drug candidate, AQX-1125, is a small molecule activator of SHIP1 suitable for oral, once daily dosing. Having successfully completed multiple preclinical studies and clinical trials with AQX-1125, Aquinox is now advancing through Phase 2 development. Aquinox has a broad intellectual property portfolio and pipeline of preclinical drug candidates that activate SHIP1. For more information, please visit www.aqxpharma.com.
SOURCE: Aquinox Pharmaceuticals
Post Views: 28
VANCOUVER, Canada I February 2, 2015 I Aquinox Pharmaceuticals, Inc. (“Aquinox”) (AQXP), a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology, today announced that it has reached its target enrollment in the Phase 2 FLAGSHIP trial of AQX-1125 for the treatment of chronic obstructive pulmonary disease (COPD) following a recent exacerbation.
“COPD has emerged as the third leading cause of death in the United States and worldwide in part due to the inability to effectively resolve and prevent exacerbations,” said David Main, President and CEO of Aquinox. “FLAGSHIP was designed to yield comprehensive insight into the effects of oral, once daily AQX-1125 on overall COPD symptoms including the frequency, severity and duration of exacerbations. We would like to thank all of the patients and investigators who participated in FLAGSHIP and we anticipate last patient final visit in May 2015 with reporting of top line data near mid-year.”
The FLAGSHIP trial is a multinational, Phase 2 clinical trial investigating the ability of AQX-1125 to reduce the effects of exacerbations in approximately 400 unstable patients with moderate to severe COPD. The FLAGSHIP trial focuses on COPD patients with a history of frequent exacerbations.
The primary endpoint of the FLAGSHIP trial is the change in the severity, duration and recurrence of symptoms associated with exacerbations in patients treated with AQX-1125 versus placebo, as measured by EXACT, a patient-reported outcome tool. Symptoms most frequently associated with COPD exacerbations include cough, breathlessness, mucus production, chest tightness and difficulty with physical exertion.
About AQX-1125
AQX-1125, Aquinox’s lead drug candidate, is a small molecule activator of SHIP1, which is a regulating component of the PI3K cellular signaling pathway. By increasing SHIP1 activity, AQX-1125 accelerates a natural mechanism that has evolved to maintain homeostasis of the immune system and reduce immune cell activation and migration to sites of inflammation. AQX-1125 has demonstrated preliminary safety and favorable drug properties in multiple preclinical studies and clinical trials. Aquinox is currently exploring AQX-1125 as an oral, once daily treatment in several Phase 2 trials.
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 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 COPD exacerbations. Symptoms most frequently associated with a COPD exacerbation, and measured by EXACT, include cough, breathlessness, mucus production, chest tightness and difficulty with physical exertion. Of COPD patients, 22-40% die within one year of a severe COPD exacerbation and 66% die within three years. Since COPD 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 the ability of AQX-1125 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 recurrence of COPD 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 trial please visit www.clinicaltrials.gov.
About Aquinox Pharmaceuticals, Inc.
Aquinox Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology. Aquinox’s lead drug candidate, AQX-1125, is a small molecule activator of SHIP1 suitable for oral, once daily dosing. Having successfully completed multiple preclinical studies and clinical trials with AQX-1125, Aquinox is now advancing through Phase 2 development. Aquinox has a broad intellectual property portfolio and pipeline of preclinical drug candidates that activate SHIP1. For more information, please visit www.aqxpharma.com.
SOURCE: Aquinox Pharmaceuticals
Post Views: 28
