Corvus Pharmaceuticals, Inc. announced the initiation of the Company?s randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis. The trial is expected to enroll 64 patients at 12 sites in the United States, with the potential for initial clinical data before year-end 2024. Corvus previously published preclinical data describing soquelitinib?s unique mechanism of action through ITK inhibition, supporting the rationale for its use in Th2-mediated diseases like atopic dermatitis.

In addition, the Company has evaluated soquelitinib in companion dogs with naturally occurring, refractory atopic dermatitis. Results from this study demonstrated soquelitinib?s potential activity in this disease. About the Soquelitinib Atopic Dermatitis Phase 1 Clinical Trial The randomized, double-blind, placebo-controlled Phase 1 clinical trial is planned to enroll 64 patients with moderate to severe atopic dermatitis that previously failed one prior topical or systemic therapy.

Patients will be randomized in a 3:1 ratio to receive one of four 28-day dosing regimens (100 mg BID, 200 mg QD, 200 mg BID, or 400 mg QD) of soquelitinib or equivalent placebo. The primary endpoints include safety and tolerability, and efficacy, which will be measured by improvement in Eczema Area and Severity Index score, Investigator Global Assessment, reduction in itch and various cytokine biomarkers. Corvus and a data monitoring committee will be able to monitor the data from the trial.

Atopic dermatitis, also called eczema, is a chronic disease that can cause inflammation, redness, scaly patches, blisters and irritation of the skin. It affects up to 20% of children and up to 10% of adults, and treatments include topical therapies, oral therapies and systemic injectable biologic therapies. It is frequently associated with other allergic disorders such as food allergies and asthma.

Atopic dermatitis, like asthma and allergy, involves the participation of Th2 lymphocytes which secrete cytokines that result in inflammation. Soquelitinib has been shown in preclinical studies to inhibit cytokine production from Th2 lymphocytes.