Takeda’s TAK-881 SCIG Product Meets Primary and Secondary Endpoints in Phase II/III Clinical Trial

Takeda’s pivotal Phase II/III clinical trial of its investigational TAK-881K (immune globulin subcutaneous [human] 20% solution [SCIG 20%] with recombinant human hyaluronidase) in patients with primary immunodeficiency (PI) met its primary endpoint, which demonstrated pharmacokinetic (PK) comparability between it and HYQVIA (immune globulin infusion [human] 10% with recombinant human hyaluronidase). Additionally, secondary endpoints showed TAK-881 demonstrated safety, efficacy and tolerability profiles comparable to HYQVIA. These findings support the potential of TAK-881 to deliver the required immune globulin (IG) dose for PI patients in half the volume of HYQVIA, reducing infusion duration while maintaining flexible, up to once-monthly dosing for patients (every three or four weeks for PI).

The TAK-881-3001 clinical trial evaluated the PK, efficacy, safety, tolerability and immunogenicity of TAK-881 in adults and pediatric patients aged 2 years and older with PI previously treated with IG therapy and compared them with HYQVIA in patients aged 16 years and older. Initial topline data show TAK-881 demonstrated equivalent immunoglobulin G (IgG) exposure between TAK-881 and HYQVIA as shown by a geometric mean ratio of 99.67% (90% CI: 95.10% to 104.46%) for the areas under the concentration-time profiles over one dosing interval at the steady state. It also demonstrated comparable infection rates and immune protection to HYQVIA, with protective IgG levels consistently maintained throughout the study. And, the safety and tolerability profiles of TAK-881 were comparable to HYQVIA, with no new safety signals observed. The safety profile of TAK-881 will continue to be evaluated in the ongoing TAK-881-3002 extension study.

“These Phase II/III results showed the pharmacokinetic profile of TAK-881 was comparable to HYQVIA, an established IG standard of care in patients with PI, 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.”