Oral TYK2 inhibitor
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Alumis Completes Patient Enrollment in the Global LUMUS Phase 2b Trial of ESK-001, a Next-Generation Oral TYK2 Inhibitor for the Treatment of Systemic Lupus Erythematosus
Globenewswireยท 2025-07-24 11:30
Core Insights - Alumis Inc. has completed patient enrollment in its global LUMUS Phase 2b trial for ESK-001, a next-generation oral TYK2 inhibitor aimed at treating systemic lupus erythematosus (SLE) [2][3] - The trial enrolled 408 patients and topline data is expected in Q3 2026, marking a significant milestone for both the company and the lupus community [3][6] - ESK-001 is designed to selectively target key inflammatory drivers, potentially offering a new treatment option for patients with SLE who currently have limited choices [3][4] Company Overview - Alumis is a late-stage biopharma company focused on developing targeted therapies for immune-mediated diseases, leveraging a proprietary data analytics platform [8] - The company's pipeline includes ESK-001 for SLE and moderate-to-severe plaque psoriasis, as well as A-005 for neuroinflammatory and neurodegenerative diseases [8] - Alumis aims to improve patient health outcomes through its innovative therapies and precision approach [8] Clinical Trial Details - The LUMUS Phase 2b trial is a randomized, double-blind, placebo-controlled study evaluating multiple doses of ESK-001 over 48 weeks [6] - The primary endpoint is to assess improvements in overall disease activity using the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Week 48 [3][6] - Following the trial, eligible patients may participate in an open-label extension or a four-week safety follow-up [3] ESK-001 Mechanism and Previous Data - ESK-001 is a highly selective TYK2 inhibitor that targets proinflammatory mediators, aiming for maximal inhibition with minimal off-target effects [4][5] - Clinical data from Alumis' psoriasis program indicates that ESK-001 effectively downregulates key cytokines and disease biomarkers, suggesting potential efficacy in reducing SLE disease activity [5] - Phase 1 studies showed that ESK-001 achieved full, sustained target inhibition and was well tolerated in healthy volunteers [5]