Takeda’s Experimental Immune Therapy Cuts Infusion Time in Late-Stage Study

Rare Daily Staff

Takeda said its experimental  treatment TAK-881 delivered the same antibody dose as its approved therapy Hyqvia in half the infusion volume, shortening treatment time for patients with primary immunodeficiency disease in a pivotal phase 2/3 study.

The study met its main goal of showing comparable exposure to immunoglobulin G, an antibody that helps protect against infections. With one infusion site, median infusion time was 75.8 minutes for TAK-881, compared with 132 minutes for Hyqvia—a reduction of 56.2 minutes, or 42.6 percent.

Takeda presented the results for participants ages 16 and older on October 14 at the European Society for Immunodeficiencies meeting in Maastricht, the Netherlands. The company plans to submit applications for approval in the United States, European Union and Japan during its fiscal year 2026.

Primary immunodeficiency disease encompasses a group of rare, chronic disorders in which part of the immune system is missing or does not work properly. Many patients need lifelong immunoglobulin replacement therapy to supply antibodies that help prevent infections. The time and volume required for infusions can add to the burden of managing these conditions.

TAK-881 is designed to reduce that burden rather than change how often patients receive treatment. It contains a 20 percent immunoglobulin solution, twice the concentration of Hyqvia’s 10 percent formulation. Both treatments are infused under the skin and include an enzyme called hyaluronidase to help the antibodies spread through the tissue and be absorbed.

The higher concentration allowed TAK-881 to deliver an equivalent antibody dose, adjusted for body weight, in 50 percent less volume while maintaining dosing every three to four weeks, Takeda said.

When patients used two infusion sites, median infusion time was 58.3 minutes with TAK-881, compared with 86 minutes with Hyqvia—a reduction of 27.7 minutes. Takeda said the lower volume could also allow some patients to use fewer infusion sites, although the release did not quantify that potential benefit.

“Reducing the administrative treatment burden is crucial for patients with primary immunodeficiency who often face lifelong immunoglobulin replacement,” said Jolan Walter, chief of pediatric allergy and immunology at the University of South Florida and Johns Hopkins All Children’s Hospital, in the company’s announcement.

The IgGNITE study enrolled patients ages 2 and older who had previously received immunoglobulin therapy. In the randomized portion, 43 participants ages 16 and older were assigned to receive TAK-881 followed by Hyqvia, or the treatments in the reverse order, using the same antibody dose and dosing interval for up to 51 weeks. Patients and investigators knew which treatment was being administered.

Children younger than 16 received TAK-881 in a separate group without a Hyqvia comparison. The newly presented results focused on the older participants. The study’s main finding concerned exposure—the amount of immunoglobulin G available in the body over time—not a statistically demonstrated reduction in infections.

Takeda reported annualized infection rates of 2.62 infections per patient-year during TAK-881 treatment and 2.73 during Hyqvia treatment. The annualized serious bacterial infection rate was about 0.056 during TAK-881 treatment; no acute serious bacterial infections were reported during Hyqvia treatment. The company described infection outcomes as comparable based on descriptive analyses.

Medical events emerging during treatment occurred in 56.1 percent of participants receiving TAK-881, or 23 of 41, compared with 50 percent receiving Hyqvia, or 19 of 38. Such events are not necessarily caused by the treatment. Takeda said the events were mild to moderate and that investigators identified no new safety signals or serious adverse events related to TAK-881.

Nine of the 43 randomized participants, or 20.9 percent, discontinued the study across the two treatment periods. No TAK-881-related adverse events led to study discontinuation, according to the company.

An ongoing phase 3 extension study is evaluating TAK-881’s long-term safety and tolerability. The treatment remains investigational and has not been approved.