Patient enrollment is complete in Alumis Inc.’s LUMUS Phase 2b trial of ESK-001, an oral tyrosine kinase 2 (TYK2) inhibitor, in systemic lupus erythematosus (SLE).
The global LUMUS Phase 2b trial is a randomized, double-blind, placebo-controlled study evaluating multiple doses of ESK-001 in adults with moderately-to-severely active, autoantibody-positive SLE. The trial enrolled 408 patients who are receiving ESK-001 or placebo for 48 weeks. The primary endpoint will be to assess improvements in overall disease activity using the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Week 48. After the trial, eligible patients may participate in an open-label extension or complete a four-week safety follow-up.
“People living with SLE face a heavy burden and few treatment options,” says Dr. Jörn Drappa, Alumis’ Chief Medical Officer, in a news release. “ESK-001, our next-generation oral TYK2 inhibitor, is designed to change that—selectively targeting key inflammatory drivers like type 1 IFN to maximize inhibition while minimizing off-target binding and effects. Clinical data in our psoriasis program has demonstrated that ESK-001 achieved full, sustained target inhibition and was generally well tolerated, positioning it as a promising oral therapy with potential for biologic-like clinical responses.”
ESK-001 is also being studied in psoriasis.
