CASI Pharmaceuticals Inc. has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug $(IND.AU)$ application for CID-103, an anti-CD38 monoclonal antibody intended to treat renal allograft antibody-mediated rejection $(AMR)$. This clearance marks a significant milestone for CASI Pharmaceuticals, a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for organ transplant rejection and autoimmune diseases. The upcoming Phase 1 clinical trial will focus on evaluating the safety, tolerability, and efficacy of CID-103 in adults with active and chronic active renal allograft AMR. The study aims to address the urgent need for new therapeutic options for patients with resistant AMR, a leading cause of kidney transplant loss.
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