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CASI Pharmaceuticals Advances CID-103 into Clinical Development for Chronic Immune Thrombocytopenia

CASI Pharmaceuticals Advances CID-103 into Clinical Development for Chronic Immune Thrombocytopenia

CASI Pharmaceuticals a biopharmaceutical company specializing in innovative therapeutic and pharmaceutical products, has announced progress in its efforts to address chronic Immune Thrombocytopenia (ITP) with the development of CID-103.

On April 12, 2024, CASI submitted the Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for CID-103 to support a phase 1/2 study in adults with chronic ITP. This submission marked a key step towards evaluating the safety and efficacy of CID-103 in patients with this serious autoimmune blood disorder.

Just over a month later, on May 13, 2024, CASI received a letter from the FDA indicating clearance for the study to proceed, signaling regulatory approval for the advancement of CID-103 into clinical trials.

CID-103, a fully human IgG1 anti-CD38 monoclonal antibody, targets a unique epitope and has demonstrated promising preclinical efficacy and safety compared to other anti-CD38 monoclonal antibodies. This innovative therapeutic candidate holds significant potential in addressing the complex mechanisms underlying ITP.

Dr. Wei-Wu He, CEO of CASI Pharmaceuticals, expressed enthusiasm for the progress of the CID-103 program, stating, "ITP is a serious autoimmune blood disorder characterized by autoantibody-mediated platelet destruction and impaired platelet production, leading to thrombocytopenia and an increased risk of life-threatening bleeding episodes. We are excited to advance this program into clinical development as CID-103 has the potential to represent a new therapeutic option to help alleviate the disease burden in this patient community."

More news about: drug discovery & development | Published by Abha | May - 16 - 2024 | 143

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