Grifols has launched two new Phase 3 clinical trials aimed at expanding the U.S. indications for its leading immunoglobulin therapies, GAMUNEX-C and XEMBIFY, as the company moves to address growing demand for immune-system treatments.
The global healthcare company announced that the first patients have been dosed in the SIGMA and XPERT studies, which will evaluate new potential uses for its intravenous and subcutaneous immunoglobulin (Ig) therapies.
The SIGMA trial will assess GAMUNEX-C, an intravenous immunoglobulin (IVIg), in combination with standard medical treatment for patients with secondary immunodeficiency (SID) linked to blood cancers and associated treatments.
The study focuses on patients with common hematologic cancers, including Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM), and Non-Hodgkin Lymphoma (NHL), conditions that collectively affect more than 1 million people in the US.
An expanded label for GAMUNEX-C could provide a new treatment option for patients whose immune systems have been weakened by cancer or therapies such as chemotherapy and B-cell-targeted treatments.
The second trial, XPERT, will evaluate whether XEMBIFY, Grifols’ subcutaneous immunoglobulin (SCIg), delivers comparable pharmacokinetic performance to GAMUNEX-C in patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP).
If successful, the findings could support future regulatory discussions around expanding XEMBIFY’s US label to include CIDP, a chronic autoimmune disorder affecting approximately 60,000 people in the country. CIDP can cause progressive weakness in the arms and legs, along with sensory changes, and immunoglobulin therapy remains a key treatment approach.
"The GBS I CIDP Foundation International embraces Grifols’ commitment to innovate and to support the patient community with additional choice in treatment and access options," said Lisa Butler, president and CEO of GBS I CIDP Foundation.
Grifols said the two trials add to its broader immunoglobulin development strategy, including the ongoing EXCELL study evaluating XEMBIFY plus standard medical treatment for patients with hypogammaglobulinemia and recurrent or severe infections associated with blood cancers.
“We’re excited about the potential to provide patients with more immunoglobulin treatment options to help manage their conditions with flexibility and convenience,” said Eduardo Herrero, Grifols’ Executive Vice President Biopharma Industrial and Scientific Innovation. “Whether it’s our IVIg or SCIg treatments, Grifols’ Igs are backed by decades of deep expertise on this protein.”
