Corvus Pharmaceuticals reported updated data from its Phase I Cohort 4 study of soquelitinib in moderate-to-severe atopic dermatitis. In this randomized, blinded, placebo-controlled U.S. trial, 24 patients were dosed at 200 mg twice daily for eight weeks. Treated patients achieved a mean 72% reduction in EASI score at week eight versus 40% in the placebo arm (p=0.035). Response rates in the active group included EASI-75 in 75% of patients, EASI-90 in 25%, and Investigator’s Global Assessment (IGA) 0/1 in 33%. Eleven of 12 soquelitinib-treated subjects reached at least EASI-50, while two placebo patients achieved EASI-75 and both required rescue medication due to flares.

Durability of response was highlighted by continued EASI reductions after treatment cessation. In earlier cohorts, responses persisted beyond a 28-day dosing period, with follow-up extending to 118 days showing maintained or improved outcomes without additional therapy. Across cohorts 1–4, 35% of patients had prior systemic treatment, rising to 50% in Cohort 4. Efficacy of soquelitinib was comparable in systemic-therapy–naïve and experienced patients, whereas placebo patients with prior exposure fared worse, underscoring the drug’s potential in a refractory population. A small subgroup of six patients resistant to their last systemic agent showed three of four soquelitinib-treated subjects improving, including two reaching EASI-90.

No new safety signals emerged during the extended eight-week dosing period. Adverse events and laboratory findings were similar between active and placebo arms, with no hepatic abnormalities, hematologic suppression, or increased infection rates observed. Management contrasted soquelitinib’s oral profile against injectable therapies by noting absence of injection-site reactions and conjunctivitis. Mechanistically, selective ITK inhibition is proposed to modulate Th2/Th17 signaling while sparing Th1 pathways. Biomarker analyses revealed reductions in serum IL-4 (Cohorts 3 and 4) and early trends toward increased functional regulatory T cells in treated patients, which may underlie sustained disease control.

Corvus plans a Phase II randomized, placebo-controlled atopic dermatitis trial in Q1 2026, enrolling 200 patients across four arms evaluating 200 mg once daily, 200 mg twice daily, 400 mg once daily, and placebo over 12 weeks plus follow-up. The primary endpoint is median EASI reduction at week 12. Additional Phase II studies in hidradenitis suppurativa and asthma are slated for 2026, while a Phase III trial in relapsed peripheral T-cell lymphoma is underway with an interim futility analysis later in the year. The company’s cash runway extends into Q4 2026, funding planned dermatology and oncology programs, and management anticipates raising further capital to support pipeline expansion.