Corvus Pharmaceuticals, Inc. (CRVS) announced positive results from Cohort 4 of its placebo-controlled Phase 1 clinical trial evaluating Soquelitinib, the company's lead ITK inhibitor, in patients with moderate-to-severe atopic dermatitis.
Atopic dermatitis is a chronic inflammatory skin condition that can severely impact quality of life, with symptoms such as persistent itching, redness, and skin lesions. Current therapies often provide incomplete relief, leaving a significant unmet need for new treatment options.
The Phase 1 trial is a randomized, double-blind, placebo-controlled study designed to assess safety, tolerability, and early efficacy signals of Soquelitinib.
Cohort 4 enrolled 24 patients randomized 1:1 to receive either 200 mg twice daily of Soquelitinib or placebo for an extended 8-week treatment period, followed by a 30-day observation period.
Key findings from Cohort 4 include:
•75% of patients achieved EASI 75 (75% improvement in Eczema Area and Severity Index).
•25% achieved EASI 90, indicating near-complete clearance.
•33% achieved IGA 0/1, reflecting clear or almost clear skin.
•Results confirmed earlier Cohort 3 findings, where patients experienced rapid itch reduction and deeper separation from placebo at the same dose but shorter duration.
The company stated that Cohort 4 results provide important insight into the durability of response at the 200 mg twice-daily dose over a longer treatment period. These data will inform the design of Corvus' planned Phase 2 trial in atopic dermatitis, expected to initiate in early Q1 2026, enrolling approximately 200 patients across multiple dose levels with a 12-week treatment period.
Richard A. Miller, co-founder and CEO of Corvus, said the Cohort 4 results "increase our confidence that Soquelitinib could become a leading oral therapy for atopic dermatitis," noting that longer treatment deepened responses without compromising safety. He added that the data also support the drug's novel ITK inhibition mechanism, designed to rebalance immune pathways across inflammatory diseases.
Beyond dermatology, Corvus continues to advance Soquelitinib in oncology. A registrational Phase 3 trial is currently enrolling patients with relapsed/refractory peripheral T-cell lymphoma (PTCL), comparing Soquelitinib to physician's choice of Belinostat or Pralatrexate.
The FDA has granted Soquelitinib Orphan Drug Designation and Fast Track designation for PTCL, underscoring its potential in this high-need indication.
Corvus reported cash and equivalents of $65.7 million as of September 30, 2025, and expects its cash position to fund operations into the fourth quarter of 2026. CRVS has traded between $2.54 and $9.60 over the past year. The stock closed January 16, 2026, trading at $8.05, up 12.75% and is currently trading in the pre-market at $12.05, up 50%, touching a new 52-week high.
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