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

Core Insights - Corvus Pharmaceuticals announced interim data from a Phase 1 clinical trial of soquelitinib for moderate to severe atopic dermatitis, showing cohort 3 (200 mg BID) had earlier and deeper responses compared to cohorts 1 and 2 [1][2][3] - The trial demonstrated a statistically significant improvement in the Eczema Area and Severity Index (EASI) score at day 28, with cohort 3 showing a mean reduction of 64.8% compared to 34.4% for placebo [1][3] - An extension cohort study has been initiated to explore the same dose of soquelitinib for a longer treatment period of 8 weeks [1][14] Efficacy Data - All three cohorts showed statistically significant separation from placebo at day 28, with cohort 3 achieving clinically meaningful reduction in itch as early as day 8 [1][4] - The mean reduction in EASI score for cohort 3 was 64.8%, while cohorts 1 and 2 combined showed a reduction of 54.6% [3][4] - At day 28, no placebo patients achieved IGA 0 or 1 or EASI 75, while cohort 3 had one patient achieving EASI 75 with an 89% reduction in EASI score [7][11] Safety Profile - As of May 28, 2025, soquelitinib was well tolerated with no new safety signals, and only one treatment-related adverse event of grade 1 nausea reported [12] - Grade 1/2 adverse events were observed in 38.9% of patients receiving soquelitinib compared to 25% in the placebo group [12] Biomarker Studies - Reductions in serum cytokines (IL-5, IL-9, IL-17, IL-31, IL-33, TSLP, and TARC) were observed, with cohort 3 showing greater reductions compared to cohorts 1 and 2 [13] - Relationships between cytokine reductions and improvements in EASI scores were noted, with no such relationships in the placebo group [13] Future Directions - The company is optimistic about the potential of soquelitinib as a safe and effective treatment for atopic dermatitis and other immune diseases, with further improvements expected from the extension cohort [2][14] - The extension cohort will enroll 24 patients randomized 1:1 between active and placebo, with an 8-week treatment period [14]