Phase I Cohort 4 Soquelitinib Yields 72% Mean EASI Reduction in AD

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Phase I Cohort 4 soquelitinib in moderate-to-severe AD achieved a 72% mean EASI reduction at eight weeks versus 40% placebo, with 75% EASI75 and 33% IGA 0/1. No new safety signals and durable responses post-treatment support a Phase II AD trial in Q1 2026.

1. Cohort 4 Delivers Robust Efficacy Signals

Corvus Pharmaceuticals presented updated Phase I data for oral soquelitinib in moderate-to-severe atopic dermatitis from a blinded, placebo-controlled U.S. study. In Cohort 4, 24 patients were randomized 1:1 to 200 mg twice daily or placebo for eight weeks. At week eight, soquelitinib achieved a mean 72% reduction in EASI score versus 40% for placebo (p=0.035). Among treated patients, 75% reached EASI 75, 25% reached EASI 90 and 33% achieved IGA 0/1. Eleven of 12 treated patients achieved EASI 50, compared with only two placebo patients who reached EASI 75 and two who required rescue medication due to flares.

2. Durable Responses and Prior-Treatment Experience

Management emphasized durability of response both during and after dosing. In earlier cohorts, responses persisted beyond the four-week treatment period and in Cohort 3 were maintained or slightly improved out to day 118 off therapy. Across Cohorts 1–4, 35% of patients had prior systemic therapy exposure; in Cohort 4 this rose to 50%. Soquelitinib’s efficacy was similar in systemic-therapy-naïve and experienced patients, while placebo patients with prior treatment fared worse, suggesting that soquelitinib may overcome unfavorable baselines associated with prior therapies. In a small subgroup resistant to their last systemic agent, three of four treated patients improved, including two reaching EASI 90.

3. Clean Safety Profile Over Extended Dosing

No new safety signals emerged in Cohort 4 despite extending treatment to eight weeks. Adverse event rates were comparable between active and placebo groups; there were no hepatic abnormalities, no significant laboratory derangements and similar infection rates. Management contrasted soquelitinib’s oral formulation with injectable atopic dermatitis therapies, noting the absence of injection-site reactions or conjunctivitis, and cited clinical-stage experience in T-cell lymphoma where no discontinuations for toxicity were reported over months to years of dosing.

4. Capital Raise to Fuel Phase II Expansion

Corvus announced an upsized public offering to extend its cash runway into late 2026 and to fund planned trials in atopic dermatitis, hidradenitis suppurativa and asthma. Gross proceeds are expected to support a randomized, placebo-controlled Phase II study in moderate-to-severe atopic dermatitis, designed to enroll 200 patients across four arms (200 mg once daily, 200 mg twice daily, 400 mg once daily and placebo) over 12 weeks with off-treatment follow-up. The company also plans Phase II initiation in two additional immune-mediated diseases and continues a Phase III registration study in peripheral T-cell lymphoma with an interim futility analysis later in the year.

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