Corvus Pharmaceuticals Announces Data from Cohorts 1-3 of Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis

Data continue to demonstrate favorable safety and efficacy profile, including earlier and deeper responses in cohort 3 compared to cohorts 1-2

Data to be presented in an oral session and poster at the Society for Investigative Dermatology 2025 Annual Meeting

Company to discuss data today on its first quarter 2025 business update conference call and webcast at 4:30 pm ET / 1:30 pm PT

Excerpt from the Press Release:

SOUTH SAN FRANCISCO, Calif., May 08, 2025 (GLOBE NEWSWIRE) — Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced new interim data from the randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis. The data demonstrated a favorable safety and efficacy profile, including earlier and deeper responses in cohort 3 (200 mg twice per day, total daily dose 400 mg) compared to cohorts 1 and 2 (100 mg twice per day and 200 mg once per day, total daily dose 200 mg). Overall, all three cohorts showed significant responses in the soquelitinib treatment groups compared to placebo for clinically significant endpoints of EASI (Eczema Area and Severity Index) 75 and IGA (Investigator Global Assessment) 0 or 1.

“We continue to be encouraged by the results from our Phase 1 trial of soquelitinib in patients with atopic dermatitis, which show a favorable safety and efficacy profile with a convenient oral tablet,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “We believe the results are particularly exciting given the relatively short treatment duration of 28 days and durable post-treatment results, both of which we associate with the novel mechanism of action provided by ITK inhibition. This is supported by biomarker studies from the trial, which show evidence of multiple effects derived from the selective blockade of ITK including the reduction of various inflammatory cytokines and the potential induction of T regulatory cells, further amplifying the disease modifying effects of soquelitinib. Based on these results, we have amended the trial protocol to evaluate an additional 24 patients at the 200 mg twice per day dose, randomized one-to-one with placebo for an extended treatment period of 8 weeks. This amendment gives us the opportunity to evaluate the potential for even stronger efficacy with longer treatment duration. This additional experience is intended to help optimize the design of a Phase 2 trial, which we are on track to initiate before the end of the year.”

Soquelitinib Interim Data from the Atopic Dermatitis Phase 1 Clinical Trial
As of May 6, 2025, enrollment into cohorts 1, 2 and 3 has been completed for a total of 48 patients. The data covers 32 patients receiving soquelitinib and 12 placebos with 28-day follow-up, and four additional patients receiving soquelitinib with 15-day follow-up from cohort 3.

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