Lupus & antiphospholipid syndrome
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
Authors' conclusion
E6742 had a favourable safety profile and was well tolerated, with suppression of IGS responses and preliminary efficacy signals in patients with SLE.
Study context
- Population
- Patients with systemic lupus erythematosus (SLE)
- Participants
- 8 / 9 / 9
- Comparison
- E6742 100 or 200 mg twice daily for 12 weeks vs placebo
- E6742 100 mgn = 8
- E6742 200 mgn = 9
- Placebon = 9reference
- Primary endpoint
- Safety (TEAEs)
Methodological detailsdouble-blind, placebo-controlled, phase I/II, first in patient, two sequential cohorts
- Double-blind
- Placebo-controlled
- Phase I/II
- First in patient
- Two sequential cohorts
Primary result
As reported in the abstract
Any TEAE
- Any TEAE, E6742 pooled
- 58.8%
Secondary outcomes
| Outcome | E6742 200 mg | Placebo |
|---|---|---|
| BICLA response (exploratory) · week 12 | 57.1% | 33.3% |
- BICLA response (exploratory): 4/7 patients for E6742 200 mg
Pharmacokinetics (PK) parameters
- Similar to previous phase I studies in healthy adults
Interferon gene signature (IGS) and proinflammatory cytokines after ex-vivo TLR7/8 agonist challenge
- Immediately decreased by E6742 treatment
Safety
Any TEAE
Any TEAE
- No CTCAE ≥Grade 3 treatment-emergent adverse events (TEAEs) occurred
Original publication
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. Published 17 September 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →