Takeda Pharmaceutical Co. Ltd. reported positive preliminary results from a Phase 2 trial of Mezagitamab (TAK-079) in treating persistent or chronic primary immune thrombocytopenia (ITP), a rare autoimmune disease. The trial, which involved a randomized, double-blind, placebo-controlled study, produced encouraging safety, tolerability, and efficacy results.
Mezagitamab, a human immunoglobulin monoclonal antibody, shows high affinity for CD38 expressing cells that contribute to several diseases. It was tested on patients with ITP using three different dosage levels and compared to a placebo over eight weeks. Interim analysis showed generally safe and well-tolerated results from Mezagitamab with a higher platelet response.
Following these positive outcomes and discussions with global health authorities, Takeda plans to start a global Phase 3 trial of Mezagitamab in ITP in 2024. By then, Takeda will have five new molecular entities in Phase 3 development, including potential treatments for psoriasis, psoriatic arthritis, narcolepsy, Lennox-Gastaut syndrome, Dravet syndrome, and 1-antitrypsin associated liver disease.
Mezagitamab has already been granted Orphan Drug Designation from the U.S. Food and Drug Administration and more recently received Fast Track Designation. According to Chinwe Ukomadu, Head of the Gastrointestinal & Inflammation Therapeutic Area Unit at Takeda, the Phase 2 results underline Mezagitamab's promising disease modifying mechanism of action and its potential for achieving disease remission in people with ITP.
