A pivotal study of a Takeda primary immunodeficiency disease (PID) asset has hit its primary endpoint, demonstrating pharmacokinetic (PK) comparability between the asset and the company’s HyQvia, which was approved to treat PID in 2014.
Takeda’s TAK-881 is a subcutaneous therapy comprising an immunoglobulin 20% solution and Halozyme’s recombinant human hyaluronidase. The candidate holds the promise of treating PID with half the infusion volume of HyQvia, which contains immunoglobulin 10%.
The increased concentration is designed to deliver the immunoglobulin (IG) dose while reducing infusion duration and maintaining once-monthly dosing for patients with PID, according to a May 4 release.
Secondary endpoints of the phase 2/3 TAK-881-3001 trial also demonstrated safety, efficacy and tolerability profiles for TAK-881 that are comparable to HyQvia, according to Takeda. The trial evaluated the candidate in adults and pediatric patients aged 2 and older with PID who had been previously treated with IG therapy, comparing the data with HyQvia's profile in patients aged 16 and older.
Topline results from the trial showed that TAK-881 demonstrated equivalent immunoglobulin G (IgG) exposure to HyQvia, as shown by a geometric mean ratio of 99.67% for the areas under the concentration-time curves over one dosing interval. The 90% confidence interval was 95.1% to 104.46%.
The asset also demonstrated comparable infection rates and immune protection to HyQvia, along with a comparable safety profile, Takeda said.
PID is a collection of over 500 rare, chronic immune disorders, making patients susceptible to severe and unusual infections. IG replacement therapy is the only treatment option to maintain immune protection, but often requires frequent and high-volume infusions.
Both TAK-881 and HyQvia are part of Takeda’s plasma-derived therapies, one of the company’s key business areas.
“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,” Kristina Allikmets, M.D., Ph.D., Takeda's SVP and head of plasma-derived therapies R&D, said in a May 4 statement.
Full analysis of the phase 2/3 is ongoing, but Takeda said it expects to submit applications for the drug to the FDA, European Union and Japan in the 2026 fiscal year, which ends in March 2027.
HyQvia came to Takeda by way of Shire, which it acquired in 2018 for $62 billion. Shire bought Baxter’s Baxalta spinoff for $32 billion and became the owner of HyQvia in 2016.
In recent years, HyQvia has seen its indications expand. The FDA approved it as a treatment for children with PID in 2023 and as a maintenance therapy for the progressive neurological disorder chronic inflammatory demyelinating polyneuropathy in 2024.