Takeda's Mezagitamab Shows Promise in Phase 2 ITP Trial

Takeda, a leading biopharmaceutical company, has reported encouraging outcomes from a Phase 2 clinical trial of mezagitamab, a monoclonal antibody targeting CD38-expressing cells, for the treatment of primary immune thrombocytopenia (ITP). The study, designated TAK-079-1004, involved a randomized, double-blind, placebo-controlled approach to assess the medication's safety, tolerability, and efficacy. Participants with chronic or persistent primary ITP were administered various doses of mezagitamab subcutaneously once weekly for eight weeks.

The interim analysis revealed that mezagitamab was generally safe and well tolerated, with all tested doses showing a higher platelet response rate than placebo. The platelet count increments were dose-dependent, with the most significant response observed at the highest dose. Notably, the treated patients experienced a rapid platelet response that was sustained even after therapy concluded.

Given the positive interim results and discussions with global health authorities, Takeda is set to initiate a global Phase 3 trial for mezagitamab in ITP during the fiscal year 2024. This advancement will contribute to Takeda's late-stage pipeline momentum, which already includes five new molecular entities in Phase 3 development.

ITP is a rare autoimmune disorder characterized by the accelerated destruction of platelets, leading to a decreased platelet count and an increased risk of bleeding. The condition can severely impact patients' quality of life and, in extreme cases, pose a life-threatening risk. Current treatments often fail to achieve a satisfactory platelet count in approximately 20% of ITP patients, highlighting an urgent need for more effective and tolerable therapies.

Chinwe Ukomadu, the head of Takeda's Gastrointestinal & Inflammation Therapeutic Area Unit, emphasized the significance of the Phase 2 results, stating that mezagitamab's disease-modifying mechanism has the potential to induce remission in ITP patients. The upcoming Phase 3 trial is anticipated to provide further evidence of the drug's efficacy and safety.

Mezagitamab has received Orphan Drug Designation from the U.S. Food and Drug Administration for ITP treatment and has also been granted Fast Track Designation. The Phase 2 trial results are not expected to affect Takeda's consolidated reported forecast for the fiscal year ending March 31, 2024.

Takeda is dedicated to improving health outcomes and advancing treatment frontiers through its diverse pipeline. The company operates with a strong commitment to patients, employees, and the environment, with a presence in approximately 80 countries and regions. Takeda's mission is to discover and deliver transformative treatments across various therapeutic areas, including gastrointestinal and inflammation, rare diseases, oncology, neuroscience, and vaccines.