Corvus Pharmaceuticals, Inc. has initiated a Phase 1 clinical trial to evaluate soquelitinib in patients with moderate to severe atopic dermatitis. This trial, which is randomized, double-blind, and placebo-controlled, aims to enroll 64 patients across 12 sites in the United States. The company anticipates the possibility of presenting initial clinical data before the end of 2024.

Dr. Richard A. Miller, the co-founder, president, and CEO of Corvus, emphasized the significance of this trial in exploring the potential of ITK inhibition for immune diseases. Soquelitinib, designed to block multiple cytokines involved in inflammation, presents a novel approach compared to current injectable biologic therapies. Dr. Miller highlighted the oral administration of soquelitinib as a potential improvement over existing treatments.

Prior to the Phase 1 trial, Corvus published preclinical data supporting soquelitinib's mechanism of action through ITK inhibition, particularly in Th2-mediated diseases like atopic dermatitis. Additionally, the company conducted studies in companion dogs with naturally occurring atopic dermatitis, which demonstrated the drug's potential efficacy in this condition.

The Phase 1 trial will involve patients who previously failed one topical or systemic therapy for atopic dermatitis. Patients will be randomly assigned to receive one of four dosing regimens of soquelitinib or a placebo, with primary endpoints including safety, tolerability, and efficacy measured through various assessments including the Eczema Area and Severity Index score and cytokine biomarkers.

Atopic dermatitis, characterized by skin inflammation and irritation, affects a significant portion of both children and adults. Current treatments include topical therapies, oral medications, and injectable biologic therapies. The disease is closely linked to other allergic conditions like food allergies and asthma.

Soquelitinib, an investigational small molecule drug, selectively inhibits ITK, primarily expressed in T cells and NK cells. Its immunologic effects lead to Th1 skewing, potentially enhancing immune responses against tumors while inhibiting the production of cytokines involved in autoimmune and allergic diseases. The drug's ability to modulate T cell differentiation holds promise for various conditions, including cancers and autoimmune disorders.

 

Source: globenewswire.com

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