TAK-881 matches HYQVIA exposure while reducing infusion volume in Phase II/III PID study

Takeda has reported detailed Phase II/III results showing that investigational TAK-881 achieved pharmacokinetic comparability with HYQVIA in patients with primary immunodeficiency disease while reducing infusion volume and administration time.

The findings come from the pivotal IgGNITE study and were presented at the 22nd Biennial Meeting of the European Society for Immunodeficiencies in Maastricht.

TAK-881 combines a 20% subcutaneous human immune globulin solution with recombinant human hyaluronidase.

If approved, Takeda said it could become the first facilitated 20% subcutaneous immunoglobulin therapy for primary immunodeficiency that can be administered as infrequently as once every three to four weeks.

The trial met its primary endpoint by demonstrating comparable immunoglobulin G exposure between TAK-881 and HYQVIA in patients aged 16 years and older.

Steady-state pharmacokinetic measures were also similar between the treatments.

Geometric mean trough IgG concentrations were 11.7 g/L with TAK-881 and 11.9 g/L with HYQVIA, remaining above accepted thresholds associated with protection from infection.

TAK-881 delivered the same bodyweight-adjusted immunoglobulin dose in 50% less volume than HYQVIA.

This reduction translated into shorter infusion times.

When administered through one infusion site, median infusion duration was 75.8 minutes with TAK-881 compared with 132 minutes for HYQVIA, representing a reduction of 56.2 minutes or 42.6%.

With two infusion sites, median infusion time was 58.3 minutes with TAK-881 compared with 86 minutes for HYQVIA.

Takeda said the lower volume could also allow treatment to be delivered through fewer infusion sites, potentially reducing the administration burden for people requiring lifelong immunoglobulin replacement therapy.

Jolan Walter, MD, PhD, Division Chief of Pediatric Allergy and Immunology at the University of South Florida and Johns Hopkins All Children’s Hospital, said lowering infusion volume and treatment time may improve the care experience for patients managing long-term therapy.

The study also showed comparable protection against infections based on descriptive analyses.

Low annualised infection rates were observed with TAK-881, while serious bacterial infection rates also remained low.

Protective IgG trough concentrations were maintained throughout treatment.

The safety profile of TAK-881 was comparable with HYQVIA and no new safety signals were identified.

Treatment-emergent adverse events occurred in 56.1% of patients receiving TAK-881 and 50.0% of those receiving HYQVIA.

Events were generally mild to moderate, and there were no TAK-881-related grade 3 or higher treatment-emergent adverse events.

No TAK-881-related serious adverse events were identified and no adverse events attributed to TAK-881 resulted in study discontinuation.

Longer-term safety is continuing to be assessed in the TAK-881-3002 extension study.

Kristina Allikmets, MD, PhD, Senior Vice President and Head of Plasma Derived Therapies Research and Development at Takeda, said TAK-881 builds on the clinical experience with HYQVIA while aiming to provide a more convenient administration option for patients with chronic immunodeficiencies.

Takeda plans to submit regulatory applications for TAK-881 in the U.S., European Union and Japan during fiscal year 2026.

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Related Topics and Keywords

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