Corvus Reports Positive Phase 1 Data For Soquelitinib, Shows Durable Efficacy And Safety In Atopic Dermatitis Trial

Corvus Pharmaceuticals reported positive results from cohort 4 of its randomized, blinded, placebo-controlled Phase 1 trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis. The latest data were consistent with findings from cohorts 1–3 and showed stronger clinical responses with extended treatment, with improvements continuing through the full eight-week dosing period.

Notably, soquelitinib demonstrated meaningful activity in patients who had previously received systemic therapies, including individuals with disease resistant to dupilumab and JAK inhibitors. Across all cohorts, treatment with soquelitinib resulted in higher rates of clinically relevant endpoints, including EASI-75 and Investigator Global Assessment (IGA) scores of 0 or 1, compared with placebo. These results support the company’s proposed mechanism of action, targeting ITK inhibition to modulate multiple T-cell pathways upstream.

“The results from cohort 4 increase our confidence that soquelitinib could become a leading oral therapy for the treatment of atopic dermatitis,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “The results also support our hypothesis from cohort 3 that the longer treatment could achieve deepening of clinical responses. Bottom line, we believe this is a successful Phase 1 program and the results have become stronger the longer we treat, without compromising safety. We believe this bodes well for advancing soquelitinib to the next phase, where we will further test soquelitinib in a larger patient population. Taken altogether, we believe the data indicate that soquelitinib has the potential to be an important new medicine for first-line or later-line therapy of patients with atopic dermatitis that could be among the most active approved or investigational drugs for this indication.”

In cohort 4, patients were randomised to receive soquelitinib 200 mg twice daily or placebo for 56 days, extending the treatment duration used in earlier cohorts. By day 56, patients treated with soquelitinib achieved a mean 72% reduction in EASI scores, compared with a 40% reduction in the placebo group. The response continued to deepen from days 28 to 56, with no disease flares reported in the soquelitinib arm, whereas flares occurred in 2 placebo-treated patients.

Dr. Miller added, “The data to date also support the novel proposed mechanism of action with ITK inhibition, which is designed to act upstream and regulate multiple T cell functional pathways. The immune rebalancing indicated thus far by soquelitinib shows its potential in a wide range of inflammatory and immune diseases.”

Safety results from cohort 4 remained favourable, with no new safety signals observed. All reported adverse events were mild to moderate, with no serious events, dose interruptions, or significant laboratory abnormalities. Based on the overall Phase 1 data, Corvus plans to initiate a Phase 2 trial in the first quarter of 2026, enrolling approximately 200 patients with moderate-to-severe atopic dermatitis who have failed at least one prior therapy.