Safety, pharmacokinetics, biomarker response and efficacy of E6742: a dual antagonist of Toll-like receptors 7 and 8, in a first-in-patient, randomised, double-blind, phase I/II study in systemic lupus erythematosus
RMD Open 2024;10:e004701 DOI 10.1136/rmdopen-2024-004701
Tanaka et al. conducted a phase I/II study to evaluate the safety, pharmacokinetics, biomarker response, and efficacy of E6742, a dual antagonist of Toll-like receptors 7 and 8, in patients with systemic lupus erythematosus (SLE). The treatment demonstrated a favourable safety profile, with no serious adverse events, while effectively suppressing interferon gene signatures and showing promising preliminary efficacy.
The study involved two sequential cohorts, with patients randomised to receive either 100 mg or 200 mg of E6742 twice daily or placebo for 12 weeks. The primary objective was to assess safety and tolerability, while secondary endpoints included pharmacokinetics and biomarker responses.