Core Insights - Alumis Inc. has completed patient enrollment in its global LUMUS Phase 2b trial for ESK-001, a next-generation oral TYK2 inhibitor targeting systemic lupus erythematosus (SLE), with topline data expected in Q3 2026 [1][5]. Company Overview - Alumis is a late-stage biopharma company focused on developing targeted therapies for immune-mediated diseases, leveraging a proprietary data analytics platform [7]. - The company is developing a pipeline of oral TYK2 inhibitors, including ESK-001 for SLE and moderate-to-severe plaque psoriasis, and A-005 for neuroinflammatory and neurodegenerative diseases [7]. Clinical Trial Details - The LUMUS Phase 2b trial is a randomized, double-blind, placebo-controlled study involving 408 patients with moderately-to-severely active, autoantibody-positive SLE, assessing the efficacy of ESK-001 over 48 weeks [2][5]. - The primary endpoint of the trial is to evaluate improvements in overall disease activity using the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Week 48 [2][5]. Drug Mechanism and Efficacy - ESK-001 is designed to selectively target key inflammatory drivers, such as type 1 interferon (IFN), aiming for maximal inhibition while minimizing off-target effects [3][4]. - Clinical data from the psoriasis program indicates that ESK-001 downregulates key cytokines and disease biomarkers, suggesting potential to reduce SLE disease activity [4]. Future Prospects - The company anticipates that ESK-001 could provide biologic-like clinical responses for SLE, based on its performance in previous clinical studies [4].
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