Pharma Pioneer

Corvus Launches Randomized Phase 1 Clinical Trial for Soquelitinib in Treating Moderate to Severe Atopic Dermatitis

16 May 2024
3 min read

Corvus Pharmaceuticals, a biopharmaceutical firm, has launched a Phase 1 clinical trial for soquelitinib, a selective ITK inhibitor, to treat moderate to severe atopic dermatitis, also known as eczema. The study, a randomized, double-blind, placebo-controlled initiative, aims to enroll 64 patients across 12 U.S. locations. The company expects to unveil preliminary data before the close of 2024. The drug is being investigated for its potential to treat a range of immune diseases and is currently in the spotlight for its application in Th2-mediated conditions like atopic dermatitis. 

Soquelitinib is anticipated to offer an oral treatment that could block multiple cytokines, which are part of the inflammatory process, unlike current therapies that typically target a single cytokine. The drug's mechanism of action has been previously outlined in preclinical studies, and it has also been tested in dogs with naturally occurring atopic dermatitis, showing promising results. The clinical trial's primary objectives are to assess the safety, tolerability, and efficacy of soquelitinib. Efficacy will be measured by improvements in various scores and biomarkers, including the Eczema Area and Severity Index and Investigator Global Assessment, as well as reductions in itch and cytokine levels. 

Corvus, along with a data monitoring committee, will oversee the trial's progress. Atopic dermatitis is a chronic inflammatory skin condition affecting a significant portion of the population, with treatments ranging from topical to systemic therapies. The condition is often linked with other allergic disorders such as asthma and involves Th2 lymphocytes, which secrete cytokines that cause inflammation. Soquelitinib has demonstrated the ability to inhibit cytokine production from these cells in preclinical studies. 

Corvus Pharmaceuticals is focused on developing ITK inhibitors for immunotherapy to treat various cancers and immune disorders. Their lead candidate, soquelitinib, is an oral small molecule that selectively targets ITK, an enzyme predominantly expressed in T cells and critical for their immune function. The drug's immunological effects are linked to Th1 skewing, a process that enhances the generation of cytotoxic T cells and cytokines that counteract cancer cell survival. It also prevents T cell exhaustion, a limitation of current immunotherapies. Soquelitinib is designed to influence T cell differentiation, promoting Th1 helper cells while inhibiting Th2 and Th17 cells, which are implicated in autoimmune and allergic diseases

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