Microarray analysis of whole blood samples (collected into PAXgene tubes from PreAnalytiX) during a phase II double-blind, randomized (1:1 ratio) clinical trial in which inhaled IFN-β (SNG001) or placebo treatment was initiated within 24 hours of asthmatics reporting cold symptoms. Patients were dosed once a day for 14 days, with samples collected at day 1 (prior to first dose), day 4 and day 7. Analysis of genome-wide gene expression (only conducted using samples from the BTS Step 4/5, mITT subgroup), showed a treatment-related enhancement of systemic innate immunity, thereby providing compelling evidence for exogenous IFN-β enhancing antiviral responses.
Overall design
Placebo versus SNG001 (IFNbeta). Day 4 (visit 3); Placebo 25 replicates, SNG001 18 replicates. Day 7 (visit 4); Placebo 28 replicates, SNG001 20 replicates.
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