Corvus Pharmaceuticals Releases Phase 1 Trial Data on Soquelitinib for Atopic Dermatitis

On January 13, 2025, Corvus Pharmaceuticals, Inc., a clinical-stage biopharmaceutical firm, shared promising new interim data from an ongoing Phase 1 clinical trial for soquelitinib, aimed at treating patients with moderate to severe atopic dermatitis. The trial, which is randomized, double-blind, and placebo-controlled, has shown encouraging safety and efficacy results. This new data includes findings from a recent cohort of 10 patients with a 28-day follow-up, as well as previous results from an earlier cohort.

The trial's initial observations reveal that patients receiving soquelitinib demonstrated substantial improvement compared to those on placebo. Specifically, significant results were noted for the clinically relevant endpoints of IGA (Investigator Global Assessment) 0 or 1 and EASI (Eczema Area and Severity Index) 75.

Dr. Richard A. Miller, co-founder, president, and CEO of Corvus, expressed optimism regarding the ongoing trial. He highlighted the enhanced outcomes from the 200 mg daily dosage in the second cohort compared to the earlier cohort's results. The efficacy endpoints, IGA 0 or 1 and EASI 75, underscore the clinical relevance of soquelitinib, setting it apart from placebo treatments where none of the patients reached these endpoints after four weeks.

Dr. Miller further emphasized soquelitinib’s potential due to its easy oral administration, safety, and unique mechanism of action. He noted that the drug is an appealing option for various immune diseases, given its ability to modulate immune system signaling pathways. Corvus expects to finalize enrollment for the atopic dermatitis trial and share comprehensive results by the second quarter of 2025. Concurrently, they are progressing with their Phase 3 registration trial for relapsed peripheral T cell lymphoma and other clinical studies.

The current data covers 16 patients in Cohort 1, where 12 received 100 mg of soquelitinib twice daily, and four were given placebo. In Cohort 2, seven patients took 200 mg of soquelitinib once daily, and three received placebo. Among the 19 patients treated with soquelitinib, 26% attained IGA 0 or 1 and 37% achieved EASI 75. In contrast, none of the placebo recipients reached these benchmarks. Notably, IGA 0 or 1 and EASI 75 are recognized by the FDA as clinically significant and approvable endpoints, which are standard in trials for other approved atopic dermatitis treatments.

The trial observed no major safety concerns or significant lab abnormalities among participants. All patients in Cohort 2 completed the 28-day regimen, with others at different treatment phases. Cohort 2 is fully enrolled with 16 participants, and Corvus intends to release full results from all study cohorts in 2025’s second quarter.

This trial is set to enroll 64 patients, each with moderate to severe atopic dermatitis who previously did not respond to one prior topical or systemic therapy. The patients are distributed across four dosing cohorts, each receiving either soquelitinib or placebo. The dosing regimens explored are 100 mg twice daily, 200 mg once daily, 200 mg twice daily, and 400 mg once daily, with a treatment duration of 28 days followed by a 30-day follow-up period without therapy.

These dosing strategies are informed by Corvus’s earlier studies involving T cell lymphoma patients. The doses for atopic dermatitis are lower than the 200 mg twice daily regimen, known for achieving complete ITK occupancy and currently being evaluated in the Phase 3 trial for peripheral T cell lymphoma.

The primary focus of the trial is on safety and tolerability, while efficacy is evaluated through improvements in EASI scores and IGA. Secondary endpoints include itch reduction and cytokine biomarker analysis. EASI scores are assessed by the percentage of patients achieving specific reductions: EASI 50, EASI 75, and EASI 90. Corvus, along with a data monitoring committee, continuously reviews trial data as the study advances.

Atopic dermatitis, or eczema, is a chronic condition causing skin inflammation, redness, and irritation, impacting up to 20% of children and 10% of adults. It is often linked with other allergic conditions like asthma and food allergies. Soquelitinib, an investigational small molecule inhibitor of interleukin-2-inducible T cell kinase (ITK), has shown promise in suppressing cytokine production from Th2 lymphocytes, which are involved in the inflammatory process of atopic dermatitis.