Corvus Pharmaceuticals (CRVS) Study result summary

Study background and rationale

• Soquelitinib is a first-in-class, selective oral ITK inhibitor targeting immune diseases, notably atopic dermatitis, with additional studies in T-cell lymphoma and other immune-mediated diseases.

• ITK inhibition reduces Th2/Th17-driven inflammation without immunosuppression, rebalancing immune function via Treg induction.

• Preclinical and clinical data support broad utility in dermatology, pulmonology, rheumatology, and oncology.

• The drug’s specificity and limited tissue distribution contribute to a favorable safety profile.

Study design and patient population

• Phase 1 trial evaluated soquelitinib in moderate to severe atopic dermatitis across four cohorts, enrolling 72 patients (48 active, 24 placebo), including those with prior systemic therapy and treatment-resistant cases.

• Cohort 4 featured 24 patients, 1:1 randomization, 8-week treatment, and 30-day follow-up; earlier cohorts used 4 weeks.

• No concomitant topical steroids were allowed during the study.

• Dosing regimens included 100 mg b.i.d., 200 mg q.d., and 200 mg b.i.d.; Cohorts 3 and 4 used 200 mg b.i.d.

• Baseline characteristics were well balanced, with 35–50% of patients having prior systemic therapy, including those resistant to previous treatments.

Efficacy results

• Cohort 4: 72% mean EASI reduction at 8 weeks (vs. 40% placebo, p=0.035); 75% achieved EASI 75, 25% EASI 90, 33% IGA 0/1.

• 92% of treated patients achieved EASI 50; no active patients required rescue medication.

• Efficacy was similar in patients with and without prior systemic therapy, including those refractory to previous treatments.

• Responses were durable, with continued disease control post-treatment and no rebound.

• Longer treatment duration in cohort 4 led to greater efficacy compared to earlier cohorts.