The trial, conducted by DeCode under a research collaboration and licensing agreement with Cephalon, was based upon DeCode's discovery of variants in the gene encoding the MAP3K9 kinase as risk factors for the development of asthma. The MAP3K9 kinase acts within a pathway targeted by CEP-1347.
“Through our genetics work we have put our finger on an important biological pathway involved in asthma; the results of this trial indicate that CEP-1347 can positively affect this pathway in a safe and well-tolerated manner,” said Kari Stefansson, CEO of DeCode.
Data on patients receiving active drug in the trial were consistent with a dose-dependent improvement in some parameters of lung function examined in the study, including methacholine challenge test and peak expiratory flow rates, as well as in a biomarker associated with asthma severity and inflammation. There was no evidence of safety and tolerability concerns.
The study was randomized, double-blind, placebo-controlled, and enrolled 160 patients divided evenly into four groups, three receiving various doses of active drug and one receiving placebo.