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news.Inflazyme Pharmaceuticals has initiated a phase IIb study comparing the effect of its drug candidate IPL512-602 with placebo in patients suffering from moderate to severe asthma.
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The purpose of the eight-week study is to assess the efficacy and safety of 20mg of IPL512-602 given once daily as an oral asthma medication. Approximately 200 male or female subjects, suffering from asthma symptoms and attacks despite taking their regular medications, will be enrolled in the study.
The drug candidate represents a new therapeutic approach that focuses on improving asthma control and reducing asthma symptoms.
The primary endpoint is an evaluation of asthma quality of life (AQLQ) using a well validated, globally accepted and FDA-recognized scoring system that has been widely used in clinical studies for other asthma drugs.
The secondary endpoints include other measures of asthma control such as night-time awakenings, need for rescue medication (short-acting beta agonists), and asthma symptoms.
In addition, changes in lung function – measured as forced expiratory volume in one second (FEV1) and morning and evening peak expiratory flow (PEFR) – will be assessed. The study is being conducted at several major asthma centers across the US, eastern Europe, Russia and the Ukraine.
“We are excited that IPL512-602 is now entering a phase IIb study which builds on the observations made in an earlier phase IIa study. Preliminary indications from that phase IIa study suggest that patients with more pronounced asthma had a clinically meaningful improvement in their AQLQ scores and other important parameters of asthma control,” said Dr Kevin Mullane, president and CEO of Inflazyme.