Early clinical evaluation of the intranasal TLR7 agonist GSK2245035: Use of translational biomarkers to guide dosing and confirm target engagement

Modulation of the airways' immune milieu is a key therapeutic goal for remission from respiratory allergies. To explore this hypothesis, GSK2245035, a selective Toll‐like receptor 7 (TLR7) agonist with preferential Type‐1 interferon (IFN)‐stimulating properties, was developed for intranasal application. Doses for clinical assessment were extrapolated from translational biomarker studies in primates. Randomized, double‐blind, placebo‐controlled trials in healthy volunteers and patients with allergic rhinitis demonstrated that intranasal GSK2245035 doses