Corvus Pharmaceuticals announced positive data from a Phase 1 trial assessing pipeline candidate soquelitinib as a treatment for moderate to severe atopic dermatitis (AD). The findings, from cohort 4 of the study, confirm and extend earlier cohorts’ outcomes, showing encouraging efficacy and a manageable safety profile for the oral interleukin-2-inducible T-cell kinase (ITK) inhibitor.

The randomized, blinded, placebo-controlled Phase 1 study is focused on AD patients previously treated with systemic therapies, including those resistant to the IL-4Rα-targeted dupilumab (Sanofi’s Dupixent) and JAK inhibitors.

In the cohort 4 data at Day 56, 75% of soquelitinib-treated patients achieved EASI 75, 25% achieved EASI 90, and 33% reached IGA 0/1, compared with lower response rates in the placebo arm. The mean reduction in Eczema Area and Severity Index (EASI) was approximately 72% vs 40% for placebo, with a statistically significant separation (p = 0.035). Safety results showed adverse events were Grade 1-2 and comparable to placebo, with no serious adverse events reported.

Corvus noted that responses deepened with the longer 8-week treatment period in cohort 4 versus earlier 4-week cohorts, and activity was observed even in patients with prior systemic therapy, including those resistant to biologics and JAK inhibitors. Corvus plans to initiate a Phase 2 randomized trial in atopic dermatitis with approximately 200 patients and multiple dose arms in early Q1 2026, marking a transition from dose exploration toward efficacy validation in a larger cohort.

Research context

Interleukin-2-inducible T-cell kinase (ITK) is a non-receptor tyrosine kinase critical for T-cell receptor signaling, making it a promising target for modulating immune responses in various T-cell-mediated diseases, including autoimmune disorders, allergies, and certain cancers. Previous interim data for soquelitinib showed dose-dependent improvements with higher regimens and early reduction in itch scores, supporting the molecule’s pharmacodynamic activity in AD. There are a small number of ITK inhibitors that have been studied or are under development, but very few have progressed in clinical developmen, with soquelitinib currently the only ITK inhibitor being actively studied, according to publicly available data.

Soquelitinib’s development is not limited to dermatology; the compound also continues in a registration Phase 3 trial for relapsed/refractory peripheral T-cell lymphoma (PTCL), underscoring the broader translational potential of ITK inhibition across immune-mediated and oncologic indications.