Takeda Launches Phase III Clinical Trial of Weekly Subcutaneous Mezagitamab (TAK-079) for Chronic Primary Immune Thrombocytopenia in China

On January 21, the Drug Clinical Trial Registry and Information Disclosure Platform showed that Takeda Pharmaceutical Company Limited registered aMezagitamab（TAK 079）Subcutaneous InjectionTreatment of Chronic Primary Immune Thrombocytopenia（ITP）Phase III Clinical Trial。

Source:Drug Clinical Trial Registration and Information Disclosure Platform

This is a randomized, double-blind, parallel-group, placebo-controlled international multicenter Phase III clinical study aimed at evaluating the efficacy and safety of Mezagitamab compared to placebo in achieving durable platelet responses in chronic ITP subjects aged ≥18 years.

The primary endpoint was achieving a sustained platelet response at Week 24., secondary endpoints included cumulative weeks with platelet counts ≥50,000/μL up to Week 24, time to first achievement of platelet count ≥50,000/μL, cumulative weeks with platelet counts ≥30,000/μL and at least doubling from baseline up to Week 24, and achievement of complete platelet response, etc.

The study involved a total of 104 institutions, including 16 from China, with the principal investigator being Dr. Renchi Yang, Chief Physician at the Institute of Hematology, Chinese Academy of Medical Sciences.ResearchIt is expected that 50 subjects will be screened in China, and 30 subjects will be enrolled.。International plan enrolls 117 subjects.

The press release shows that Mezagitamab is a fully human immunoglobulin IgG1 monoclonal antibody.（mAb）, for cells expressing CD38(including plasmablasts, plasma cells, and natural killer cells)With high affinity, leading to the exhaustion of these cells. Mezagitamab can provide rapid and sustained improvement in platelet response and restore platelet counts to functional levels.The product is injected subcutaneously once a week.

Source: Takeda Official Website

In June 2024, Takeda announced positive data from the Phase IIb clinical study of Mezagitamab for the treatment of ITP patients. The results showed that, compared with placebo, Mezagitamab demonstrated efficacy across three different doses.(100mg, 300mg, and 600mg)BelowAll achieved improvement in platelet response.，Platelet count also increased rapidly and continuously.In terms of safety, no new safety signals were identified, consistent with previous studies.

Insight database shows that currently there are 18 CD38 monoclonal antibodies globally.(Only counting new drugs with projects in an active state)Under development, two products have been marketed, respectively.Isatuximab(Sanofi)and Daratumumab(Johnson & Johnson), in addition, there is 1 product in the application stage for market approval.(Phesetuzumab,MorphoSys/I-Mab Biopharma）。

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