Takeda reveals positive data from Phase IIb trial of ITP treatment

Takeda has reported positive results from its Phase IIb trial of mezagitamab (TAK-079) for primary immune thrombocytopenia (ITP), a rare bleeding disorder. This double-blind, randomized, placebo-controlled study aimed to assess mezagitamab's safety, tolerability, and effectiveness.

The trial tested mezagitamab at doses of 100mg, 300mg, and 600mg against placebo. The primary endpoint was the incidence of Grade 3 or higher treatment emergent adverse events, serious adverse events, and adverse events leading to mezagitamab discontinuation.

Secondary endpoints included platelet responses, complete platelet responses, clinically significant platelet responses, and hemostatic platelet responses. Mezagitamab demonstrated significant increases in platelet counts across all doses compared to placebo.

Patients receiving mezagitamab experienced rapid and sustained platelet count improvements lasting up to 16 weeks post-treatment. The 600mg dose showed the most substantial efficacy, with 81.8% achieving complete platelet responses.

Mezagitamab-treated patients also reported fewer bleeding-related adverse events than those on placebo, and its safety profile was consistent with previous studies. Takeda plans to initiate a global Phase III trial in the second half of fiscal year 2024 (FY2024).