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Takeda’s New Data on Mezagitamab Shows Promise in ITP Treatment

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Takeda Pharmaceuticals has announced encouraging results from its Phase 2b study of mezagitamab, showing potential to transform the treatment of primary immune thrombocytopenia (ITP). The study revealed that mezagitamab-treated patients experienced rapid and sustained increases in platelet counts that persisted eight weeks after the last dose, showcasing the drug’s potential to offer long-term benefits in platelet maintenance.

The randomized, double-blind, placebo-controlled trial evaluated three different doses of subcutaneous mezagitamab (100mg, 300mg, and 600mg) compared to placebo. Results demonstrated that mezagitamab significantly improved platelet responses across all dose levels. The highest dose (600mg) showed the most significant results, with 81.8% of patients achieving complete platelet response and 100% achieving hemostatic platelet response. This highlights the efficacy of mezagitamab in producing strong clinical outcomes across varied dosing regimens.

Patients treated with mezagitamab also experienced fewer bleeding-related adverse events compared to those on placebo (17.9% vs 46.2%). “Despite current treatments, there is still a significant disease burden in ITP,” said Dr. David Kuter, a leading ITP expert. “These results are encouraging and highlight mezagitamab’s potential as a disease-modifying treatment.” This underscores the need for innovative therapies that can provide better management of ITP.

The safety profile of mezagitamab was consistent with previous studies, with no new safety signals observed. The rates of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and discontinuations due to adverse events were similar between the mezagitamab and placebo groups. This consistency in safety data reinforces the potential for mezagitamab to be a well-tolerated option for patients with ITP, reducing concerns about adverse effects.

treatment

Takeda Advances Mezagitamab for ITP Treatment

“Having these results selected for the ISTH Congress underscores the significance of our findings,” said Dr. Obi Umeh, Vice President at Takeda. “We plan to initiate a Phase 3 study of mezagitamab in ITP later this year, aiming to meet the high unmet needs of patients.” This step forward signifies Takeda’s commitment to advancing treatments that can significantly impact patient care and quality of life.

Mezagitamab is a fully human immunoglobulin IgG1 monoclonal antibody targeting CD38-expressing cells, including plasmablasts and plasma cells. It has received Orphan Drug and Fast Track Designations from the FDA for the treatment of ITP. The ongoing research is expected to further establish its efficacy and safety profile. These designations from the FDA highlight the promising nature of mezagitamab in addressing critical gaps in current ITP treatments.

The Phase 2b trial’s primary endpoint was the percentage of patients with Grade 3 or higher TEAEs, SAEs, and discontinuations due to adverse events. Secondary endpoints included various measures of platelet response. In the trial, participants received weekly subcutaneous injections of mezagitamab or placebo for eight weeks, followed by at least eight weeks of safety follow-up. This trial structure ensures comprehensive evaluation of both short-term and long-term effects of the drug on patients.

ITP is an autoimmune disease characterized by the accelerated destruction of platelets, leading to a decreased platelet count and increased risk of bleeding. It affects patients’ quality of life and can be life-threatening in severe cases. The need for effective and tolerable treatments remains high, as current therapies do not achieve sustained platelet counts in all patients. This emphasizes the importance of ongoing research and development in finding better solutions for managing this chronic condition.

 

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Resource: Takeda, June 24

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