Zenas BioPharma: First patient dosed in Phase 3 clinical study of obexelimab

KUALA LUMPUR, Jan 12 (Bernama) -- Global biopharmaceutical company, Zenas BioPharma, has announced that the first patient has been dosed in the INDIGO Phase 3 registrational study of obexelimab.

According to Zenas in a statement, the INDIGO study will evaluate the clinical efficacy and safety of obexelimab treatment in the prevention of IgG4-related disease (IgG4-RD) flare.

Obexelimab is a high-affinity bifunctional antibody that inhibits B-cell lineages by simultaneously binding to CD19 and FcүRIIB, thereby downregulating B-cell activity in patients with autoimmune diseases associated with autoantibodies, such as IgG4-RD.

“IgG4-RD is a chronic and serious fibroinflammatory condition that can affect nearly any organ system and can have a profound impact on many patients, leading to severe organ damage or death. There are no currently approved treatments for patients living with IgG4-RD.

“Based upon the promising data from a Phase 2 study of obexelimab in IgG4-RD patients, we are excited to continue to evaluate the potential of obexelimab in the INDIGO study,” said Zenas chief executive officer, Dr Hua Mu.

Approximately 20,000 people are diagnosed with IgG4-RD in the United States, with similar prevalence rates across geographies. Many patients have some degree of irreversible organ damage at the time of diagnosis.

With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas of high unmet medical need while meeting the value requirements of the dynamic global healthcare environment.

-- BERNAMA