CAMBRIDGE, Mass. — Takeda said a pivotal Phase 2/3 clinical trial of its investigational immune globulin therapy TAK-881 met its primary endpoint in patients with primary immunodeficiency disease, supporting the therapy’s potential to reduce infusion volume and treatment time while maintaining immune protection.
The trial, TAK-881-3001, showed pharmacokinetic comparability between TAK-881 and HYQVIA, Takeda’s established immune globulin therapy. TAK-881 is a 20% subcutaneous immune globulin solution given with recombinant human hyaluronidase, while HYQVIA is a 10% subcutaneous immune globulin therapy also facilitated with hyaluronidase.
Takeda said the findings suggest TAK-881 could deliver the required immune globulin dose for patients with primary immunodeficiency disease in half the volume of HYQVIA. The company said the therapy could also reduce infusion duration while preserving flexible dosing of up to once monthly, including every three or four weeks for primary immunodeficiency disease.
The study evaluated TAK-881 in adults and children ages 2 and older with primary immunodeficiency disease who had previously received immune globulin therapy. In patients ages 16 and older, TAK-881 was compared with HYQVIA in an open-label, randomized crossover portion of the trial. Children ages 2 to under 16 received TAK-881 only in an open-label, single-arm portion of the study.
Takeda said the study met its primary endpoint by demonstrating equivalent immunoglobulin G exposure between TAK-881 and HYQVIA. The geometric mean ratio was 99.67%, with a 90% confidence interval of 95.10% to 104.46%, for the area under the concentration-time curve over one dosing interval at steady state.
Secondary endpoints showed TAK-881 had safety, efficacy and tolerability profiles comparable to HYQVIA. The company said TAK-881 maintained protective immunoglobulin G levels throughout the study and demonstrated comparable infection rates and immune protection. No new safety signals were observed, though Takeda said safety will continue to be evaluated in the ongoing TAK-881-3002 extension study.
“These Phase 2/3 results showed the pharmacokinetic profile of TAK-881 was comparable to HYQVIA, an established IG standard of care in patients with PID, while offering the potential advantages of fewer injection sites, a flexible treatment schedule and shorter infusion times,” said Kristina Allikmets, MD, PhD, Senior Vice President and Head of Plasma Derived Therapies R&D at Takeda. “TAK-881-3001 reflects our broader R&D commitment to advancing next-generation IG therapies and bringing meaningful new treatment options to patients faster, while expanding patient choice and upholding rigorous standards of efficacy and safety.”
Primary immunodeficiency disease refers to a group of disorders in which the immune system does not work properly, leaving patients more vulnerable to infections. For many patients, immune globulin replacement therapy is the only treatment option to help maintain protection against infection. Although existing therapies are effective, Takeda said patients can still face a significant treatment burden from frequent or high-volume infusions.
“Patients needing lifelong IG therapy for PID experience a significant burden of care. Improving the administration process can diminish the burden of care by substantively impacting the treatment experience,” said Richard L. Wasserman, MD, PhD, allergist/immunologist and principal investigator for TAK-881-3001. “These topline results from TAK-881-3001 are encouraging. They show that a highly concentrated, hyaluronidase-facilitated subcutaneous IG can provide immune protection with a more manageable infusion experience intended to enhance the day-to-day lives of patients living with PID.”
Takeda said analyses from TAK-881-3001 are ongoing and additional results are expected to be presented at a future medical forum. The company expects to submit regulatory applications for TAK-881 in the U.S., European Union and Japan in fiscal year 2026.
