Grifols has dosed the first patients in two separate Phase III trials designed to support the US label expansion of its immunoglobulin therapies, Gamunex-C and Xembify.
The studies are being conducted to evaluate the potential for extending approved indications and providing additional treatment options for immune system-related conditions.
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The SIGMA trial will assess Gamunex-C, an intravenous immunoglobulin (IVIg), in combination with standard medical treatment for patients with secondary immunodeficiency (SID).
It will focus on individuals with conditions such as B-cell chronic lymphocytic leukaemia, multiple myeloma, and non-Hodgkin lymphoma.
Furthermore, the study aims to demonstrate that the rate of serious bacterial infections is less than one per participant per year in this patient group.
The open-label, multi-centre, single-arm study involves 50 participants who have hypogammaglobulinaemia and a history of these blood cancers.
Meanwhile, the XPERT trial is evaluating the subcutaneous immunoglobulin (SCIg) Xembify in around 40 patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
The multi-centre trial will compare the pharmacokinetics, safety, and efficacy of XEMBIFY with GAMUNEX-C as maintenance therapy. It is being conducted at approximately 20 sites across the US and Europe.
GAMUNEX-C already carries an indication for CIDP in the US; XPERT will seek to establish whether XEMBIFY is non-inferior for this use.
The new trials build on Grifols’ ongoing immunoglobulin research programme, which also includes the EXCELL trial announced in late 2022.
Grifols Biopharma industrial and scientific innovation executive vice-president Eduardo Herrero said: “We’re excited about the potential to provide patients with more immunoglobulin treatment options to help manage their conditions with flexibility and convenience. Whether it’s our IVIg or SCIg treatments, Grifols’ Igs are backed by decades of deep expertise on this protein.”
In November 2024, Grifols subsidiary GigaGen commenced a Phase I dose escalation trial, with the first patient receiving a dose of GIGA-2339, a recombinant polyclonal drug candidate aimed at treating hepatitis B virus infection.
