Corvus’ Soquelitinib Delivers Positive Phase 1 Results In Atopic Dermatitis, With Strongest Response At Highest Dose

Corvus Pharmaceuticals has announced promising interim results from its Phase 1 clinical trial of soquelitinib, a novel therapy for patients with moderate to severe atopic dermatitis. The randomised, double-blind, placebo-controlled study revealed that soquelitinib was both safe and effective, with the highest dose group (cohort 3: 200 mg twice daily) showing faster and deeper clinical responses than lower-dose groups.

Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus, said in a statement, “We continue to be encouraged by the results from our Phase 1 trial of soquelitinib in patients with atopic dermatitis, which show a favourable safety and efficacy profile with a convenient oral tablet. We believe the results are particularly exciting given the relatively short treatment duration of 28 days and durable post-treatment results, both of which we associate with the novel mechanism of action provided by ITK inhibition. 

He further added, “This is supported by biomarker studies from the trial, which show evidence of multiple effects derived from the selective blockade of ITK, including the reduction of various inflammatory cytokines and the potential induction of T regulatory cells, further amplifying the disease-modifying effects of soquelitinib. Based on these results, we have amended the trial protocol to evaluate an additional 24 patients at the 200 mg twice per day dose, randomised one-to-one with placebo for an extended treatment period of 8 weeks. This amendment gives us the opportunity to evaluate the potential for even stronger efficacy with longer treatment duration. This additional experience is intended to help optimise the design of a Phase 2 trial, which we are on track to initiate before the end of the year.”

The trial enrolled 48 patients, with 36 receiving soquelitinib and 12 on a placebo. As of May 6, 2025, 32 patients had completed a full 28-day treatment course, while 4 patients in the highest-dose group were mid-treatment. The results showed that all three dosing regimens of soquelitinib achieved superior results versus placebo on key measures such as EASI-75 (75% improvement in Eczema Area and Severity Index) and IGA scores of 0 or 1, which indicate clear or almost-clear skin. Notably, cohort 3 included patients with more severe baseline disease and a greater history of failed systemic therapies, yet still exhibited robust improvements.