Takeda has announced promising mid-stage results for mezagitamab (TAK-079) in patients with persistent or chronic primary immune thrombocytopenia (ITP).
The phase 2b results were presented at the 32nd Congress of the International Society on Thrombosis and Haemostasis and the company plans to initiate a global phase 3 trial in the second half of 2024.
Affecting approximately four in every 100,000 people every year, ITP is a rare, immunoglobulin (IgG)-mediated autoimmune disease characterised by a low platelet count and tiny blood cells responsible for preventing or stopping bleeding.
The TAK-079-1004 trial has been evaluating once-weekly 100mg, 300mg and 600mg subcutaneous mezagitamab versus placebo for eight weeks in patients with chronic or persistent primary ITP, followed by over eight weeks of safety follow-up.
The fully human IgG1 monoclonal antibody therapy with high affinity for CD38 expressing cells is designed to deliver rapid and sustained improvement in platelet response and to restore platelet counts to functional levels.
Results demonstrated that treatment with mezagitamab significantly improved platelet response across all three dose levels tested, compared to placebo, as well as a rapid and sustained increase in platelet counts that persisted eight weeks after the final dose.
In addition, more than 81% of patients treated with mezagitamab dose of 600mg achieved a complete platelet response, while nearly 91% achieved a meaningful platelet response and 100% demonstrated haemostatic platelet response.
Furthermore, mezagitamab had a favourable safety and tolerability profile in patients with ITP, with no new safety signals reported and a safety profile consistent with previous studies.
The therapy previously received Orphan Drug Designation and Fast Track Designation for the treatment of chronic/persistent ITP from the US Food and Drug Administration, which has not yet been approved for use.
Obi Umeh, vice president, franchise global programme leader, Takeda, commented: “Based on these results, we plan to initiate a phase 3 study of mezagitamab in ITP in the second half of 2024, further underscoring our goal to develop transformative treatments in therapeutic areas with high unmet patient needs.”
Last year, Takeda announced positive phase 3 results of its enzyme replacement therapy, TAK-755, in congenital thrombotic thrombocytopenic purpura, an ultra-rare, chronic and debilitating blood clotting disorder.