Corvus Pharmaceuticals announced on March 12, 2025, the initiation of a Phase 2 clinical trial of soquelitinib for the treatment of patients with Autoimmune Lymphoproliferative Syndrome (ALPS). This trial for the rare genetic disease is being conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), in partnership with Corvus.
The trial is designed to enroll up to 30 patients aged 16 or older with confirmed ALPS-FAS, evaluating soquelitinib doses of 200 mg or 400 mg twice per day for up to 360 days. The primary endpoint is efficacy, measured by reductions in splenomegaly and lymph node volumes, with improvements in cytopenias as a secondary endpoint.
This marks the third clinical indication under development for soquelitinib, leveraging preclinical evidence that ITK inhibition can address the immune dysregulation in T cells characteristic of ALPS. The collaboration with NIH/NIAID provides external validation and resources, highlighting the broad potential of ITK inhibition to restore immune balance in both oncology and immune diseases.
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