{"id":87989,"date":"2023-08-01T12:31:42","date_gmt":"2023-08-01T12:31:42","guid":{"rendered":"https:\/\/pr.asianetpakistan.com\/?p=111695"},"modified":"2023-08-01T12:31:42","modified_gmt":"2023-08-01T12:31:42","slug":"zenas-biopharma-announces-publication-of-phase-2-study-of-obexelimab-an-investigational-treatment-for-igg4-related-disease-igg4-rd-in-the-lancet-rheumatology","status":"publish","type":"post","link":"https:\/\/jordannewsgazette.com\/zenas-biopharma-announces-publication-of-phase-2-study-of-obexelimab-an-investigational-treatment-for-igg4-related-disease-igg4-rd-in-the-lancet-rheumatology\/","title":{"rendered":"Zenas BioPharma Announces Publication of Phase 2 Study of Obexelimab, an Investigational Treatment for IgG4-Related Disease (IgG4-RD), in The Lancet Rheumatology"},"content":{"rendered":"
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Study found obexelimab produced rapid, strong, and sustained clinical improvement, including complete clinical remission, in most patients with active IgG4-RD<\/em><\/p>\n

Results support the continued development of obexelimab for the treatment of IgG4-RD and potentially other B cell-mediated autoimmune conditions<\/em><\/p>\n

WALTHAM, Mass., Aug. 01, 2023 (GLOBE NEWSWIRE) — Zenas BioPharma, a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies, announces 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.<\/p>\n

IgG4-RD is a chronic, immune-mediated fibro-inflammatory disease that 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.<\/p>\n

Across the world, the use of glucocorticoids is widely considered to be the standard of care for treating IgG4-RD. 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. Such therapies also impair vaccine responses, including those for SARS-CoV-2 and influenza.<\/p>\n

In a prospective, open-label, single arm, single-center pilot study to assess the efficacy and safety of obexelimab in the treatment of patients with IgG4-RD (clinicaltrials.gov<\/a> registration NCT02725476), obexelimab demonstrated strong improvement in the IgG4-RD Responder Index, a measure of disease activity, by inhibiting B cell function, without depleting B cells.<\/p>\n

The published manuscript, titled \u201cObexelimab for the Treatment of Patients with IgG4-Related Disease: An Open-Label, Single-Arm, Pilot Study to Evaluate Efficacy, Safety, and Mechanism of Action,\u201d is available online and will appear in the August issue of The Lancet Rheumatology 2023;5(8) [E428-E429].<\/p>\n

The following are the key findings in the paper:<\/p>\n