Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS) has announced promising interim data from its Phase 1 clinical trial of soquelitinib for patients with moderate to severe atopic dermatitis. The randomized, double-blind, placebo-controlled trial demonstrated a favorable safety and efficacy profile for the investigational drug, suggesting it could become a valuable treatment option for this chronic skin condition.
The data, which includes results from Cohort 1 and initial data from Cohort 2, showed significant responses in the soquelitinib treatment groups compared to placebo, as measured by clinically significant endpoints of IGA (Investigator Global Assessment) 0 or 1 and EASI (Eczema Area and Severity Index) 75. These endpoints are recognized by the FDA as indicators of clinical benefit and have been used in the approval of other atopic dermatitis treatments.
Phase 1 Trial Results
The Phase 1 trial enrolled patients with moderate to severe atopic dermatitis who had previously failed topical or systemic therapies. The trial design included four dosing cohorts, with patients receiving either soquelitinib or placebo in a 3:1 ratio. The doses examined were 100 mg orally twice per day, 200 mg orally once per day, 200 mg orally twice per day, and 400 mg orally once per day, administered for 28 days followed by a 30-day observation period.
In the soquelitinib group, 26% of patients achieved IGA 0 or 1, and 37% achieved EASI 75. In contrast, none of the patients in the placebo group reached these endpoints. No significant safety issues or clinically significant laboratory abnormalities were observed.
"As we increase the number of patients, we remain excited by the outlook for our Phase 1 clinical trial of soquelitinib for the treatment of atopic dermatitis," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. He added that the data from Cohort 2, evaluating a 200 mg once-a-day dose, appeared better than the initial results from Cohort 1. Dr. Miller believes soquelitinib will be attractive to physicians and patients due to its convenient oral administration, safety, and novel mechanism of action.
Soquelitinib's Potential
Soquelitinib (formerly CPI-818) is an investigational small molecule drug designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme expressed predominantly in T cells. ITK plays a crucial role in T cell and natural killer (NK) cell immune function. By inhibiting ITK, soquelitinib can modulate T cell differentiation and cytokine production, potentially benefiting patients with cancer and autoimmune/allergic diseases.
Ongoing and Future Studies
Corvus Pharmaceuticals is also advancing a Phase 3 registration trial of soquelitinib in relapsed peripheral T cell lymphoma (PTCL). The company plans to report full results from the atopic dermatitis trial in the second quarter of 2025.
About Atopic Dermatitis
Atopic dermatitis, also known as eczema, is a chronic inflammatory skin disease affecting up to 20% of children and 10% of adults. Current treatments include topical therapies, oral therapies, and systemic injectable biologic therapies. The disease is often associated with other allergic disorders, such as food allergies and asthma.
Corvus Pharmaceuticals is pioneering the development of ITK inhibition as a novel approach to immunotherapy for a broad range of cancer and immune diseases.
