CRVS · Corvus Pharmaceuticals, Inc.

Corvus Pharmaceuticals disclosed final results from its randomized, placebo-controlled Phase 1 trial of soquelitinib, a selective ITK inhibitor, in 72 patients with moderate-to-severe atopic dermatitis who had failed prior topical or systemic therapy. The trial featured four cohorts with escalating doses up to 200 mg twice daily over 28 or 56 days, demonstrating a clear dose-dependent efficacy trend and enhanced benefit with extended dosing in cohort 4. Key efficacy metrics in the highest dose cohorts included 50% EASI 75 achievement in cohort 3 and 75% in cohort 4, with substantial IGA 0/1 responses and sustained disease control through extended follow-up periods without rebound, contrasting with typical approved therapies. Safety was favorable across cohorts, with adverse event rates matching placebo and no serious events or lab abnormalities. Biomarker data robustly validated the mechanism, showing blockade of Th2/Th17 pathways, cytokine reductions (IL-4, IL-5, IL-13, TARC), increased persistent Treg cells via Th17-to-Treg switch, and JAK-STAT inhibition via SOCS3 upregulation. These findings, presented at the SID Annual Meeting, underscore soquelitinib's potential for drug-free remissions and immune rebalancing without broad immunosuppression. Ongoing Phase 2 enrollment in SIERRA1 and partner trials in China position this as a pipeline advancement for investors.