OSAKA, Japan & CAMBRIDGE, Mass. - Takeda Pharmaceutical Company (NYSE:TAK) Limited (TSE:4502/NYSE:TAK) has reported positive results from a Phase 2 study on mezagitamab, a treatment for primary immune thrombocytopenia (ITP), a rare autoimmune disorder. The trial, which is part of the company's late-stage pipeline, demonstrated the drug's safety and efficacy, prompting plans for a global Phase 3 trial in the fiscal year 2024.
The Phase 2 study, known as TAK-079-1004, was a randomized, double-blind, placebo-controlled trial assessing mezagitamab's safety and platelet response in patients with chronic or persistent ITP. The interim analysis showed that the drug was well-tolerated and led to a dose-dependent increase in platelet counts, with the most significant response at the highest dose. This increase was rapid and sustained after therapy.
Mezagitamab, an IgG1 monoclonal antibody targeting CD38 expressing cells, is designed to deplete these cells, which are implicated in the destruction of platelets in ITP patients. The condition is characterized by a low platelet count and increased risk of bleeding. Mezagitamab has already received Orphan Drug and Fast Track Designations from the U.S. Food and Drug Administration for the treatment of ITP.
Chinwe Ukomadu, Head of the Gastrointestinal & Inflammation Therapeutic Area Unit at Takeda, stated that the Phase 2 results support mezagitamab's potential as a disease-modifying treatment. The company is eager to commence the Phase 3 trial and present the data at an upcoming scientific congress.
Takeda's commitment to addressing unmet medical needs is further evidenced by its expanding Phase 3 pipeline, which includes treatments for psoriasis, psoriatic arthritis, narcolepsy, Lennox-Gastaut syndrome, Dravet syndrome, and α1-antitrypsin associated liver disease.
The results of the mezagitamab trial are not expected to affect Takeda's consolidated forecast for the fiscal year ending March 31, 2024. The information regarding mezagitamab's progress is based on a press release statement from Takeda Pharmaceutical Company Limited.
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