Global biopharmaceutical company, Zenas BioPharma, announced The Lancet Rheumatology has published findings from a Phase 2 study evaluating obexelimab for the treatment of patients with IgG4-Related Disease (IgG4-RD).
Based on the results of this study, a Phase 3 study in patients with IgG4-RD is ongoing to further investigate the efficacy and safety of obexelimab administered as a subcutaneous injection, according to a statement.
A chronic, immune-mediated fibro-inflammatory disease, IgG4-RD can affect multiple organs including the major salivary glands, orbits, lacrimal glands, pancreas, biliary tree, lungs, kidneys and retroperitoneum.
Approximately 20,000 patients are diagnosed with IgG4-RD in the United States alone. Despite its increasing recognition, there remains a need for further research and effective therapeutic options for individuals living with this debilitating disease.
Among the key findings, obexelimab produced rapid, strong and sustained clinical improvement including complete remission in most patients with active IgG4-RD; and during obexelimab treatment, reductions in circulating B cells were observed without evidence of cell death.
Additionally, reduction of circulating B cells and rapid return to near normal levels after treatment discontinuation suggests that obexelimab may lead to B cell sequestration in lymphoid organs or the bone marrow.
The use of glucocorticoids is widely considered to be the standard of care for treating IgG4-RD, worldwide, but there are no approved treatment options for this condition.
While commonly used, glucocorticoids and available B cell depleting therapies rarely lead to long-term, treatment-free remissions, and are associated with a high risk of toxicity in these patients.
In a prospective, open-label, single arm, single-centre pilot study to assess the efficacy and safety of obexelimab in the treatment of patients with IgG4-RD, obexelimab demonstrated strong improvement in the IgG4-RD Responder Index, a measure of disease activity, by inhibiting B cell function, without depleting B cells.
The published manuscript is available online and will appear in the August issue of The Lancet Rheumatology.
Source: BERNAMA News Agency
