21 July 2022 - - ADVANCE-1, a randomized, placebo-controlled, double-blind Phase 3 clinical trial evaluating Hyqvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] for the maintenance treatment of chronic inflammatory demyelinating polyradiculoneuropathy, met its primary endpoint, Japan-based Takeda (TSX: 4502) (NYSE: TAK) said.

Topline data show that Hyqvia reduced relapse of neuromuscular disability and impairment when used as a maintenance therapy for CIDP, supporting its potential as a facilitated subcutaneous immunoglobulin (fSCIG) solution that could allow for monthly infusion for many CIDP patients.

Analyses from ADVANCE-1 are ongoing, and the company anticipates disclosing additional data in an upcoming medical forum.

The pivotal ADVANCE-1 clinical trial evaluated the efficacy, safety and tolerability of Hyqvia in 132 adult patients with CIDP who had been on a stable dosing regimen of intravenous immunoglobulin therapy for at least three months prior to infusion.

Analysis of the primary endpoint shows that Hyqvia, when administered at the same dose and dosing interval as the patient's previous IVIG, reduced CIDP relapse as compared to placebo [9.7% vs 31.4%, respectively; p-value = 0.0045], as measured by Inflammatory Neuropathy Cause and Treatment (INCAT).

The majority of patients in the study received a four-week dosing regimen of HYQVIA.

Chronic inflammatory demyelinating polyradiculoneuropathy is a rare and chronic autoimmune disease that affects the peripheral nervous system.

The condition results in progressive symmetric weakness and impaired sensory function in the arms and legs.

Immunoglobulin therapy has become standard of care for CIDP patients due to its broad, multifaceted, anti-inflammatory and immunomodulatory effect.

In topline analyses of ADVANCE-1, Hyqvia showed a favorable safety profile, further supporting its use as a maintenance therapy for CIDP.

Of the 62 patients treated with HYQVIA, the majority of treatment-related adverse events were reported as mild or moderate. No new safety risks were reported with Hyqvia.

The safety profile of Hyqvia in CIDP will be further supported by data from the ongoing ADVANCE-3 clinical trial, the longest extension study of its kind with up to six years of follow-up data on some participants.

Upon full data analyses, Takeda intends to submit applications for HYQVIA to regulatory authorities in the United States and European Union in fiscal year 2022.

ADVANCE-1 was a Phase 3, multicenter, placebo-controlled, double-blinded study to evaluate the efficacy, safety and tolerability of Hyqvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] as a maintenance therapy to prevent relapse in chronic inflammatory demyelinating polyradiculoneuropathy.

The global study included 132 adults with a confirmed diagnosis of CIDP and who had remained on a stable dosing regimen of intravenous immunoglobulin therapy for at least three months prior to screening.

The primary endpoint of the clinical trial was the proportion of subjects who experienced a worsening of functional disability, defined as an increase of ≥1 point relative to the pre-subcutaneous treatment baseline score in two consecutive adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability scores.

Some of the secondary endpoints included time to relapse, effect on activities of daily living, safety and tolerability.

Patients were randomized to receive either Hyqvia or placebo at the same dose and infusion frequency as their prior IVIG treatment (every two, three or four weeks) for six months or until relapse.

Patients who relapsed were offered IVIG treatment with Gammagard Liquid (Kiovig) for a period of six months as part of the open-label rescue arm of the study (ADVANCE-2).

Those who remained relapse free were offered to continue Hyqvia treatment as part of ADVANCE-3, an open-label extension clinical trial to assess the long-term safety, tolerability and immunogenicity of Hyqvia in participants with CIDP who completed ADVANCE-1.