Favourable results for mAb in bleeding disorder shared at ISTH

Immune thrombocytopenia test

Takeda has shared positive results from its Phase IIb study evaluating the safety, tolerability and efficacy of mezagitamab (TAK-079) in patients with persistent or chronic primary immune thrombocytopenia (ITP), a rare immune-mediated bleeding disorder.

ITP is characterised by the accelerated destruction of platelets in blood, resulting in a decreased platelet count and an increase of bleeding that can be debilitating.

The trial results demonstrated that mezagitamab treatment improved platelet response compared to placebo, across all three dose levels of mezagitamab tested.

The data were presented at the 32nd Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Bangkok, Thailand.

Takeda also announced plans to initiate a global Phase III trial of mezagitamab in patients with ITP in the second half of 2024.

The TAK-079-1004 trial evaluated three different doses of subcutaneous mezagitamab (100mg, 300mg and 600mg) versus placebo, given once weekly for eight weeks in patients with chronic or persistent primary ITP.

The primary endpoint was the percentage of patients with at least one Grade 3 or higher treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to mezagitamab discontinuation.

Secondary endpoints included platelet response, complete platelet response, clinically meaningful platelet response, and haemostatic platelet response.

Patients treated with mezagitamab showed rapid and sustained increases in platelet counts (above the 50,000/μL therapeutic threshold), that persisted eight weeks after the last dose through to Week 16.

On the highest 600mg dose, 81.8% achieved complete platelet response, 90.9% clinically meaningful platelet response, and 100% haemostatic platelet response.

Fewer mezagitamab-treated patients compared to placebo had ≥1 disease activity-related bleeding AE (17.9% vs 46.2%, respectively).

Favourable efficacy and safety in ITP

“Despite treatment with currently available therapies, there is still a significant disease burden and need for a disease modifying treatment that people living with ITP can tolerate,” said David Kuter, a leading expert in ITP and study presenter at the ISTH. “These Phase IIb trial results are especially encouraging because they show mezagitamab’s favourable efficacy and safety profile – setting the stage for the generation of additional clinical evidence for this anti-CD38 monoclonal antibody with best-in-class potential for efficacy in ITP.”

Mezagitamab is a fully human immunoglobulin IgG1 monoclonal antibody (mAb), with high affinity for CD38 expressing cells (including plasmablasts, plasma cells, natural killer cells), resulting in their depletion.

Mezagitamab previously received Orphan Drug Designation for the treatment of ITP and Fast track Designation for treatment of chronic/persistent ITP from the US Food and Drug Administration.

Diana Spencer, Senior Digital Content Editor, DDW

Related Articles

Join FREE today and become a member
of Drug Discovery World

Membership includes:

  • Full access to the website including free and gated premium content in news, articles, business, regulatory, cancer research, intelligence and more.
  • Unlimited App access: current and archived digital issues of DDW magazine with search functionality, special in App only content and links to the latest industry news and information.
  • Weekly e-newsletter, a round-up of the most interesting and pertinent industry news and developments.
  • Whitepapers, eBooks and information from trusted third parties.
Join For Free