CASI Pharmaceuticals, Inc. (Nasdaq:CASI) has announced the first patient dosed in its Phase 1/2 clinical trial of CID-103 for the treatment of chronic Immune Thrombocytopenia (ITP) in China. This trial aims to evaluate the safety and tolerability of CID-103 in adult patients suffering from this autoimmune condition.
CID-103: A Novel Anti-CD38 Monoclonal Antibody
CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody. It is designed to recognize a unique epitope on CD38, a transmembrane glycoprotein expressed on various immune cells. Preclinical studies have indicated that CID-103 has a promising efficacy and safety profile compared to other anti-CD38 monoclonal antibodies.
Clinical Trial Details
The Phase 1/2 trial is designed to assess the safety, tolerability, and dose-response of CID-103 in adult patients with chronic ITP. The study will provide critical data to guide the future development of CID-103, potentially expanding its use to other autoimmune indications with significant unmet medical needs.
"Dosing the first patient in our phase 1/2 study marks a significant milestone for both CID-103 program and chronic ITP patients who have limited treatment options," said Dr. Wei-Wu He, Chairman and CEO of CASI. "The rapid execution underscores our commitment to accelerating clinical development. This phase 1/2 study is designed to deliver important safety and dose-response data, providing valuable insights to guide the future development of CID-103 for additional autoimmune indications with significant unmet medical needs."
Immune Thrombocytopenia (ITP) and Unmet Needs
Immune Thrombocytopenia (ITP) is an autoimmune disorder characterized by a low platelet count, leading to an increased risk of bleeding. Current treatment options are limited, and many patients do not achieve sustained remission, highlighting the need for novel therapies.
CASI's Strategic Focus
CASI Pharmaceuticals is focused on developing and commercializing innovative therapeutics for hematology-oncology, organ transplant rejection, and autoimmune diseases. The company aims to become a leader in the Greater China market by leveraging its regulatory and commercial expertise.
