Ouro Medicines, which is developing immune reset therapeutics for people living with chronic, immune-mediated diseases, has announced that gamgertamig, the company’s BCMAxCD3 T cell engager antibody investigational candidate, has been granted U.S. Food and Drug Administration (FDA) Fast Track designation for development in the treatment of autoimmune haemolytic anaemia (AIHA) and for immune thrombocytopenia (ITP).
“Fast Track designation for gamgertamig in both AIHA and ITP underscores the need for new treatment options in these potentially life-threatening conditions,” said Neely Mozaffarian, chief medical officer of Ouro Medicines.
“Our ongoing clinical trial of gamgertamig in autoimmune cytopenias, including AIHA and ITP, combined with our study in Sjögren’s disease and idiopathic inflammatory myopathies, will continue to generate meaningful data in these indications, offering the potential of an immune reset approach which could redefine the standard of care for these immune-mediated conditions. We are highly encouraged by the data generated to date in Ouro-sponsored and investigator-initiated studies of gamgertamig in several indications.”
In addition, gamgertamig has been granted U.S. FDA Orphan Drug Designation (ODD) for development in the treatment of AIHA and ITP.
Ouro Medicines is evaluating gamgertamig in an open-label, multinational, basket study being conducted in the US and Australia in adult participants with active autoimmune cytopenias, including relapsed/refractory AIHA, ITP, or both. The study evaluates safety, tolerability and pharmacokinetics of gamgertamig administered via subcutaneous injection, with the primary endpoint evaluated at Week 12. Dosing has been completed in the first cohort, with enrolment actively ongoing in subsequent cohorts.
In addition to development in autoimmune cytopenias, Ouro Medicines is conducting an open-label, multinational, basket study in adult participants with active, autoantibody-positive, relapsed/refractory Sjögren’s disease or idiopathic inflammatory myopathy (which includes dermatomyositis, polymyositis, immune-mediated necrotizing myopathy and anti-synthetase syndrome).