Takeda has unveiled positive results from its Phase IIb clinical trial of mezagitamab (TAK-079) for treating primary ITP.
The double-blind, randomised, placebo-controlled trial focused on assessing the safety, tolerability and efficacy of mezagitamab in people with this rare bleeding disorder.
In the trial, mezagitamab at doses of 100mg, 300mg and 600mg was assessed against placebo.
The percentage of subjects with a minimum of one Grade 3 or higher treatment emergent adverse events, serious adverse events and adverse events (AEs) leading to mezagitamab discontinuation was the trial’s primary endpoint.
Platelet, complete platelet, clinically meaningful platelet responses, and hemostatic platelet response were the secondary endpoints.
The trial's findings showed that all three mezagitamab doses enhanced platelet counts versus placebo.
Subjects in the mezagitamab arm had quick and lasting rises in platelet counts that persisted eight weeks after the last dose through to week 16.
Notably, the 600mg dose yielded the most significant responses, with 81.8% of patients achieving a complete platelet response.
Patients receiving mezagitamab experienced fewer bleeding AEs than those on placebo.
The safety and tolerability profile of mezagitamab was in line with prior studies without any new concerns detected.
Takeda is now preparing for a global Phase III trial set to commence in the second half of the fiscal year 2024 (FY2024).
These latest findings were presented at the oral Late-Breakthrough Session at the 32nd Congress of the International Society on Thrombosis and Haemostasis in Thailand.
Takeda franchise global programme leader vice-president Obi Umeh said: “It is a privilege to have these Phase IIb mezagitamab results selected for presentation as a late-breaking abstract at the ISTH Congress.
“Based on these results, we plan to initiate a Phase III study of mezagitamab in ITP in the second half of FY2024, further underscoring our goal to develop transformative treatments in therapeutic areas with high unmet patient needs.”
