Novel TK1 Inhibitor Demonstrates Rapid, Dose-Dependent Efficacy in Atopic Dermatitis in Ph 1 Trial

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Corvus Pharmaceuticals' oral IL-2-inducible T cell kinase (ITK) inhibitor soquelitinib demonstrated significant efficacy over placebo in treating adults with moderate to severe atopic dermatitis, according to interim data from a phase 1 randomized clinical trial released by the company on May 8.

Participants receiving 200 mg twice daily achieved a 71.1% reduction in mean Eczema Area and Severity Index (EASI) scores after 28 days compared to 42.1% for placebo, with clinical responses emerging as early as day 8 of treatment, according to a Corvus statement.

The trial evaluated 48 adults who had not responded to at least one prior topical or systemic therapy. Participants were randomly assigned to 1 of 3 dosing cohorts, with those in the highest dose group (200 mg twice daily) showing earlier and deeper responses than those following the 100 mg twice daily (cohort 1) regimen and 200 mg once daily (cohort 2) regimen. Notably, the drug maintained a favorable safety profile across cohorts, with only 1 treatment-related adverse event (grade 1 nausea) reported among patients receiving the active medication.

Richard A. Miller, Corvus co-founder and CEO, highlighted the drug's potentially unique mechanism of action through selective ITK inhibition, which appears to reduce inflammatory cytokines and induce T regulatory cells. "We believe the results are particularly exciting given the relatively short treatment duration of 28 days and durable post-treatment results," Miller stated.

Previously the company has noted that “…the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with cancers, including solid tumors, and in patients with autoimmune and allergic diseases.”²

The Phase 1 study enrolled patients with moderate to severe disease who had failed at least one prior topical or systemic therapy. Patients in cohort 3 had more severe disease at baseline compared to earlier cohorts, with higher mean EASI scores and a greater proportion who had failed previous systemic treatments. Despite this, this higher-dose group showed superior responses. Across all cohorts, the mean EASI scores are 22.3 and 21.2 for active and placebo, respectively. Placebo (n=12) and active (n=36) treatment groups were well-balanced with regard to baseline characteristics, according to the statement.

The study measured clinically meaningful endpoints established by the FDA for atopic dermatitis treatments. The researchers reported that no participants in the placebo-treated group achieved either an IGA (Investigator Global Assessment) score of 0 or 1 (clear or almost clear skin) or EASI 75. In contrast, the combined soquelitinib treatment group showed statistically significant superiority to placebo at day 28 (p=0.03).

Biomarker studies revealed reductions in multiple serum cytokines including IL-5, IL-9, IL-17, IL-31, IL-33, TSLP, and TARC, with differences observed between responders and non-responders. Investigators also noted increasing trends in circulating T regulatory cells, consistent with the drug's proposed mechanism of action.

Based on these interim results, Corvus has amended the trial protocol to replace the planned fourth cohort with an extended evaluation, according to the statement. The company will now study 24 additional adults at the 200-mg twice daily dose for an extended 8-week treatment period with a follow-up period of 30 days without treatment. The amendment is designed to explore whether longer treatment duration produces stronger efficacy, Corvus said.

The doses evaluated in the atopic dermatitis trial parallel those used in the company's ongoing registrational phase 3 clinical trial of soquelitinib in peripheral T cell lymphoma.

The company expects to initiate a phase 2 trial before year-end, incorporating insights from this extended cohort to optimize the study design.

References

1. Corvus Pharmaceuticals announces data from cohorts 1-3 of placebo-controlled phase 1 clinical trial of soquelitinib for atopic dermatitis. News release. Corvus Pharmaceuticals. May 8, 2025. Accessed May 12, 2025. https://investor.corvuspharma.com/news-releases/news-release-details/corvus-pharmaceuticals-announces-data-cohorts-1-3-placebo
2. Corvus Pharmaceuticals announces interim data from placebo-controlled phase 1 clinical trial of soquelitinib for atopic dermatitis. Corvus Pharmacetuicals. News release. December 18, 2024. Accessed May 8, 2025. https://investor.corvuspharma.com/news-releases/news-release-details/corvus-pharmaceuticals-announces-interim-data-placebo-controlled
3. Corvus Pharmaceuticals announces data from cohorts 1-3 of placebo-controlled phase 1 clinical trial of soquelitinib for atopic dermatitis. Corvus Pharmaceuticals. News release. May 8, 2025. Accessed May 8, 2025. https://investor.corvuspharma.com/news-releases/news-release-details/corvus-pharmaceuticals-announces-data-cohorts-1-3-placebo
4. Corvus Pharmaceuticals announces interim data from placebo-controlled phase 1 clinical trial of soquelitinib for atopic dermatitis. Corvus Pharmacetuicals. News release. December 18, 2024. Accessed May 8, 2025. https://investor.corvuspharma.com/news-releases/news-release-details/corvus-pharmaceuticals-announces-interim-data-placebo-controlled