Takeda (TSE:4502/NYSE) unveiled encouraging findings from its Phase 2b study, which evaluated mezagitamab (TAK-079) in patients with persistent or chronic primary immune thrombocytopenia (ITP), a rare bleeding disorder caused by accelerated platelet destruction. Presented at the 32nd Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Bangkok, Thailand, the data underscore mezagitamab’s potential to improve platelet counts effectively and sustainably.
The TAK-079-1004 trial (NCT04278924) assessed subcutaneous mezagitamab at doses of 100mg, 300mg, and 600mg versus placebo over eight weeks, followed by >8 weeks of safety monitoring. Primary endpoints focused on adverse events, while secondary measures included platelet response and bleeding episodes. Results indicated robust platelet increases with mezagitamab, particularly at the 600mg dose, achieving significant complete and clinically meaningful platelet responses.
Dr. David Kuter, presenting at ISTH, emphasized the trial’s promising outcomes, highlighting mezagitamab’s favorable safety profile and potential as a transformative therapy for ITP. Following these results, Takeda plans to launch a Phase 3 trial in the second half of FY2024, aiming to address unmet patient needs in this challenging condition.
Mezagitamab, a CD38-targeting monoclonal antibody, has previously received Orphan Drug Designation and Fast Track Designation from the FDA for chronic/persistent ITP. It remains investigational pending regulatory approval.
The Phase 2b trial’s interim analysis at ISTH provided pivotal insights into mezagitamab’s efficacy in managing ITP, reinforcing its role in potentially altering treatment paradigms for this debilitating disease.
