Corvus Pharmaceuticals Reports Phase 1 Trial Data for Soquelitinib in Atopic Dermatitis

Corvus Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company based in Burlingame, California, has revealed promising interim results from its Phase 1 clinical trial of soquelitinib for treating moderate to severe atopic dermatitis. The trial is a randomized, double-blind, placebo-controlled study aimed at assessing the safety and efficacy of soquelitinib, an investigational oral medication targeting interleukin-2-inducible T cell kinase (ITK). These initial findings suggest that soquelitinib could offer a novel mechanism of action for managing atopic dermatitis and potentially other immune-related disorders.

In the study, Corvus enrolled 64 patients with moderate to severe atopic dermatitis, all of whom had previously failed at least one topical or systemic therapy. Participants were divided into four dosing cohorts, receiving either soquelitinib or a placebo. The trial evaluated several dosing strategies, including 100 mg twice daily, 200 mg once daily, 200 mg twice daily, and 400 mg once daily. Each patient underwent a 28-day treatment period, followed by a 30-day observation period without therapy.

The primary objectives of the trial were to assess safety, tolerability, and efficacy, as measured by the Eczema Area and Severity Index (EASI), the Investigator Global Assessment (IGA), itch reduction, and cytokine biomarker changes. Efficacy outcomes were further evaluated by the percentage of patients achieving specific reductions in EASI scores, such as EASI 50, EASI 75, and EASI 90.

Corvus has reported complete results from Cohort 1, which included 16 participants. Patients receiving soquelitinib demonstrated significant improvements in EASI scores compared to the placebo group. At 28 days, the soquelitinib group showed an average EASI score reduction of 55.9%, in contrast to a 27.0% reduction seen in the placebo group. By 58 days, the soquelitinib group exhibited an average EASI score reduction of 69.1%, while the placebo group had a reduction of just 19.1%.

Notably, in the soquelitinib cohort, nine of the 12 patients achieved at least a 50% reduction in EASI scores by day 28, and these improvements persisted, with continued success at day 58. The trial also highlighted early onset effects, with noticeable improvements starting at eight days. All patients treated with soquelitinib showed some level of EASI score reduction, underscoring the drug's potential efficacy.

Regarding safety, no significant adverse events were reported in the soquelitinib group. Two patients experienced mild issues: one reported Grade 1 nausea, and another contracted COVID-19 but recovered without complications. Overall, the safety profile of soquelitinib was deemed favorable, with no laboratory abnormalities detected.

The trial's data also indicate a correlation between clinical responses and reductions in certain cytokines, such as IL-5, IL-17, IL-31, IL-33, and TSLP, only observed in the soquelitinib group.

In addition to the promising results from the first cohort, Corvus shared initial outcomes from Cohort 2, involving 12 patients treated with soquelitinib 200 mg once daily. As of early December, data from three patients reflected efficacy trends similar to those in Cohort 1, with no significant lab abnormalities or treatment-related adverse events reported.

Besides the clinical trial updates, Corvus announced a financial boost from the early exercise of common stock warrants by Samlyn Capital, resulting in cash proceeds of approximately $12.7 million. This development strengthens the company's financial position as it continues to advance its innovative therapies.

Corvus Pharmaceuticals is committed to exploring the potential of ITK inhibition as a new therapeutic strategy across a spectrum of immune diseases. Soquelitinib, designed to selectively inhibit ITK, is at the forefront of this research, with ongoing trials evaluating its efficacy in other conditions such as peripheral T cell lymphoma. The company remains optimistic about the future development of soquelitinib and its potential impact on the treatment landscape for atopic dermatitis and other immune-related disorders.