Takeda's Once-Weekly Subcutaneous CD38 Monoclonal Antibody Mezagitamab Granted New Clinical Trial Approval in China for Immune Thrombocytopenia

Dec 17, 2024 09:07 CST Updated 09:08

Takeda

Biopharmaceutical Manufacturer

▎WuXi AppTec Content Team Report

December 16,The latest announcement on the website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA),Takeda's Class 1 new drug mezagitamab injection has received a new clinical trial implied permission, intended for development to treatPrimary Immune Thrombocytopenia（ITP）Publicly available information shows that Mezagitamab is a fully human immunoglobulin IgG1 monoclonal antibody (mAb),High affinity for CD38-expressing cells (including plasmablasts, plasma cells, and natural killer cells), leading to their depletion.Mezagitamab treatment aims to provide rapid and sustained improvement in platelet response and restore platelet counts to functional levels.

Screenshot Source: CDE official website

Immune thrombocytopenia is a common autoimmune bleeding disorder., characterized by accelerated antibody-mediated platelet destruction and impaired production, with some patients facing the threat of severe bleeding, reduced quality of life, and increased risk of death. CD38-positive long-lived plasma cells (LLPC) can continuously produce pathogenic antibodies, leading to disease relapse or refractoriness, which is considered one of the key reasons why durable clinical benefits in ITP patients cannot be achieved merely by depleting CD20-positive B cells. Therefore,Targeting the CD38 molecule to eliminate antibody-secreting cells, including long-lived plasma cells, holds promise for providing new benefits in the treatment of immune thrombocytopenia.

In June this year, Takeda announced positive results from a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and efficacy of mezagitamab in patients with persistent or chronic primary immune thrombocytopenia (ITP).The trial, named TAK-079-1004, evaluatedThree different doses of subcutaneous injection of mezagitamab(100 mg, 300 mg, and 600 mg) compared to placebo in terms of efficacy and safety in ITP patients,Once weekly for 8 weeks, followed by a safety follow-up of more than 8 weeks.

The test results showed,Mezagitamab treatment significantly improved platelet response at all three dose levels. Patients receiving mezagitamab showed a rapid and sustained increase in platelet counts, an effect that persisted for 8 weeks after the last dose until week 16., demonstrating the rapid and sustained efficacy of mezagitamab on platelet response.

Among all evaluated platelet response indicators,600 mg Patients in the mezagitamab dose group performed the best, specifically,81.8% of patients achieved complete platelet response, 90.9% achieved clinically significant platelet response, and 100% achieved hemostatic platelet response.。

According toClinicalTrialsAccording to the official website, Takeda has launched an international multi-center Phase 3 clinical study for mezagitamab in treating adult patients with chronic ITP this December.In China, Takeda has completed the Phase 2 clinical study of this product for the treatment of persistent/chronic primary immune thrombocytopenia. The recent implied permission for clinical trials indicates new progress in China.

References:

[1] Website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA). Retrieved Dec 16, 2024, from https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c

[2]Takeda Presents Late-Breaking Data from Phase 2b Study of Mezagitamab, Demonstrating Potential to Transform Treatment of Primary Immune Thrombocytopenia. Retrieved June 24, 2024, from https://www.takeda.com/newsroom/newsreleases/2024/late-breaking-data-from-phase-2b-study-of-mezagitamab/

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