Corvus Pharmaceuticals Announces Initiation of Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis

Atopic dermatitis is the first immune disease indication being studied in the clinic for soquelitinib, the Company’s selective ITK inhibitor

Corvus anticipates releasing initial clinical data from trial before year-end 2024

BURLINGAME, Calif., April 09, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today 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.

“The initiation of our Phase 1 atopic dermatitis trial is an important step towards unlocking the broad potential of ITK inhibition for immune diseases,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “Soquelitinib has the potential to improve the treatment landscape for atopic dermatitis by providing an oral medication designed to block multiple cytokines involved in the inflammatory process, compared to current injectable biologic therapies that only inhibit one or a limited number of cytokines. We look forward to ramping up enrollment with the potential to share initial data from the trial before year-end, while also working to initiate our soquelitinib registrational Phase 3 trial for PTCL.”

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.