Alumis, a late-stage biopharmaceutical company, has completed patient enrollment for its Phase 2b LUMUS trial of ESK-001, an oral TYK2 inhibitor, for systemic lupus erythematosus (SLE). The trial enrolled 408 patients and aims to evaluate the drug’s efficacy and safety over 48 weeks, with topline results expected in Q3 2026. This trial is crucial for the SLE community as it investigates a new potential treatment option for this chronic autoimmune disease with limited existing therapies.
This advancement is particularly significant due to the unmet need in SLE treatment. Current options often have limited efficacy or significant side effects. ESK-001’s mechanism, selectively inhibiting TYK2, a key enzyme in inflammatory pathways, offers a potential for improved treatment with fewer off-target effects, potentially leading to better outcomes for patients. This trial’s progress also signals increasing investment and research interest in SLE, potentially leading to more treatment options in the future.
The LUMUS trial is a randomized, double-blind, placebo-controlled study evaluating multiple doses of ESK-001 in adults with moderate-to-severe SLE. The primary endpoint is the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) score at 48 weeks, measuring overall disease activity. Previous Phase 1 trials in psoriasis demonstrated ESK-001’s sustained target inhibition and good tolerability, and preclinical data suggest it can downregulate key inflammatory pathways implicated in SLE. Alumis is also currently conducting Phase 3 trials for ESK-001 in psoriasis.
The completion of enrollment in the LUMUS trial sets the stage for potentially pivotal results in 2026. Positive data could lead to a significant advancement in SLE treatment and position ESK-001 as a leading oral therapeutic option. This could also further validate Alumis’s precision medicine platform and spur further development of its pipeline for other immune-mediated diseases. The outcome of this trial will likely influence future research directions and treatment strategies for SLE, impacting both patients and the pharmaceutical landscape.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
