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Corvus Pharmaceuticals Announces Initiation of Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis
免疫疗法临床3期
Atopic dermatitis is the first immune disease indication being studied in the clinic for soquelitinib, the Company’s selective ITK inhibitor
Corvus anticipates releasing initial clinical data from trial before year-end 2024
April 09, 2024 -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced the initiation of the Company’s randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis. The trial is expected to enroll 64 patients at 12 sites in the United States, with the potential for initial clinical data before year-end 2024.
“The initiation of our Phase 1 atopic dermatitis trial is an important step towards unlocking the broad potential of ITK inhibition for immune diseases,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “Soquelitinib has the potential to improve the treatment landscape for atopic dermatitis by providing an oral medication designed to block multiple cytokines involved in the inflammatory process, compared to current injectable biologic therapies that only inhibit one or a limited number of cytokines. We look forward to ramping up enrollment with the potential to share initial data from the trial before year-end, while also working to initiate our soquelitinib registrational Phase 3 trial for PTCL.”
Corvus previously published preclinical data describing soquelitinib’s unique mechanism of action through ITK inhibition, supporting the rationale for its use in Th2-mediated diseases like atopic dermatitis. In addition, the Company has evaluated soquelitinib in companion dogs with naturally occurring, refractory atopic dermatitis. Results from this study demonstrated soquelitinib’s potential activity in this disease.
About the Soquelitinib Atopic Dermatitis Phase 1 Clinical Trial
The randomized, double-blind, placebo-controlled Phase 1 clinical trial is planned to enroll 64 patients with moderate to severe atopic dermatitis that previously failed one prior topical or systemic therapy. Patients will be randomized in a 3:1 ratio to receive one of four 28-day dosing regimens (100 mg BID, 200 mg QD, 200 mg BID, or 400 mg QD) of soquelitinib or equivalent placebo. The primary endpoints include safety and tolerability, and efficacy, which will be measured by improvement in Eczema Area and Severity Index score, Investigator Global Assessment, reduction in itch and various cytokine biomarkers. Corvus and a data monitoring committee will be able to monitor the data from the trial.
About Atopic Dermatitis
Atopic dermatitis, also called eczema, is a chronic disease that can cause inflammation, redness, scaly patches, blisters and irritation of the skin. It affects up to 20% of children and up to 10% of adults, and treatments include topical therapies, oral therapies and systemic injectable biologic therapies. It is frequently associated with other allergic disorders such as food allergies and asthma. Atopic dermatitis, like asthma and allergy, involves the participation of Th2 lymphocytes which secrete cytokines that result in inflammation. Soquelitinib has been shown in preclinical studies to inhibit cytokine production from Th2 lymphocytes.
About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancer and immune diseases. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit www.corvuspharma.com.
About Soquelitinib
Soquelitinib (formerly CPI-818) is an investigational small molecule drug given orally designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme that is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell immune function. The immunologic effects of soquelitinib lead to what is known as Th1 skewing and is made possible by the high selectivity of soquelitinib for ITK. Research on soquelitinib’s mechanism of action suggests that it has the potential to control differentiation of normal T helper cells and enhance immune responses to tumors by augmenting the generation of cytotoxic killer T cells and the production of cytokines that inhibit cancer cell survival. Soquelitinib has also been shown to prevent T cell exhaustion, a major limitation of current immunotherapy and CAR-T therapies. Optimal doses of soquelitinib have been shown to affect T cell differentiation and induce the generation of Th1 helper cells while blocking the development of both Th2 and Th17 cells and production of their secreted cytokines. Th1 T cells are required for immunity to tumors, viral infections and other infectious diseases. Th2 and Th17 helper T cells are involved in the pathogenesis of many autoimmune and allergic diseases. The Company believes 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.
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