CAMBRIDGE, Mass. — Takeda has announced detailed results from its Phase 2/3 IgGNITE clinical trial showing that its experimental treatment TAK-881 could reduce infusion times and treatment burden for patients with primary immunodeficiency disease (PID).
The findings, presented at the 22nd Biennial Meeting of the European Society for Immunodeficiencies in Maastricht, the Netherlands, showed that TAK-881 met its primary endpoint by demonstrating comparable drug exposure to Takeda’s existing immunoglobulin therapy, HYQVIA.
TAK-881 is an investigational 20% subcutaneous immunoglobulin treatment designed for administration every three to four weeks. If approved, it could become the first facilitated subcutaneous immunoglobulin therapy at that concentration offering up to once-monthly dosing for patients with PID.
Primary immunodeficiency disorders weaken the body’s ability to fight infections, often requiring lifelong immunoglobulin replacement therapy. Current treatments can involve lengthy infusions, large fluid volumes and multiple infusion sites.
According to Takeda, TAK-881 delivered the same immunoglobulin dose as HYQVIA in 50% less fluid volume while significantly reducing administration times.
For patients receiving treatment through one infusion site, median infusion times were 75.8 minutes with TAK-881 compared with 132 minutes for HYQVIA, a reduction of 56.2 minutes, or 42.6%.
For patients using two infusion sites, median administration times declined from 86 minutes with HYQVIA to 58.3 minutes with TAK-881.
“Reducing the administrative treatment burden is crucial for patients with primary immunodeficiency who often face lifelong immunoglobulin replacement,” said Jolan Walter, MD, PhD, division chief of pediatric allergy and immunology at the University of South Florida and Johns Hopkins All Children’s Hospital.
“By halving infusion volume, the facilitated SCIG 20% meaningfully shortened administration times while maintaining once-monthly dosing – delivering consistent protection while potentially giving patients back time,” Walter added.
The IgGNITE trial evaluated TAK-881 in adults and children aged 2 and older who had previously received immunoglobulin therapy. Participants aged 16 and older underwent a randomized crossover comparison of TAK-881 and HYQVIA, while younger patients received TAK-881 in a separate study group.
Among participants aged 16 and older, the treatments produced comparable immunoglobulin G concentrations, with average trough levels of 11.7 grams per liter for TAK-881 and 11.9 grams per liter for HYQVIA.
Infection outcomes were also similar, with annualized infection rates of 2.62 for TAK-881 and 2.73 for HYQVIA.
Takeda reported no new safety signals or TAK-881-related serious adverse events. Treatment-emergent adverse events occurred in 56.1% of participants receiving TAK-881 and 50% of those receiving HYQVIA, with reported events generally mild to moderate.
Nine of the 43 randomized participants discontinued the study across both treatment periods, although no discontinuations were attributed to TAK-881-related adverse events.
“Building on the trusted clinical heritage of HYQVIA through insights shaped by our ongoing dialogue with the PID community, TAK-881 reflects our efforts to improve the day-to-day care experience for individuals with chronic immunodeficiencies,” said Kristina Allikmets, MD, PhD, senior vice president and head of Plasma Derived Therapies R&D at Takeda.
Allikmets said the investigational treatment could provide patients with a more convenient administration option while maintaining the established safety and effectiveness of immunoglobulin therapies.
Long-term safety is being evaluated in the ongoing TAK-881-3002 extension study.
Takeda said it plans to advance TAK-881 through regulatory review as it seeks to expand treatment options for patients with primary immunodeficiency disorders.
