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Inflazyme begins phase 2b trial with IPL512,602 for asthma
By Lisa Kerner
Erie, Pa., May 10 - Inflazyme Pharmaceuticals Ltd. started its phase 2b study called Capsics (Control of Asthma Patients Symptomatic on Inhaled Corticosteroids Study) with IPL512,602 in 200 patients suffering from moderate to severe asthma.
The eight-week, randomized, double-blind, parallel group, multi-center trial is comparing the efficacy and safety of IPL512,602 (20mg given once daily) to a placebo.
Inflazyme said the primary endpoint is an evaluation of Asthma Quality of Life using a Juniper scoring system. Secondary endpoints include nighttime awakenings, need for rescue medication and asthma symptoms, according to a company news release.
The study will also assess changes in lung function as well as morning and evening peak expiratory flow.
"Preliminary indications from that phase 2a study suggest that patients with more pronounced asthma had a clinically meaningful improvement in their AQLQ [Asthma Quality of Life] scores and other important parameters of asthma control," president and chief executive officer Dr. Kevin Mullane said in the release.
"These beneficial effects will be further examined in patients that have more debilitating moderate to severe forms of asthma, many of whom respond poorly to standard medications and remain uncontrolled."
According to the Centers for Disease Control, 21 million adults and 9 million children were diagnosed with asthma in 2003. The number of people worldwide suffering from asthma is expected to grow to 400 million by 2025, the release stated.
Inflazyme is a Vancouver, B.C., biopharmaceutical company specializing in respiratory and inflammatory diseases.
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