EMA grants orphan drug designation to XOMA 358 to treat congenital hyperinsulinism

CHI refers to several congenital disorders in which hypoglycemia is caused by excessive insulin secretion.

Itis a rare genetic disorder in which the insulin cells of the pancreas secrete inappropriate and excessive insulin. 

XOMA 358 is a negative allosteric antibody that binds to the insulin receptor and down-regulates insulin action. 

The US Food and Drug Administration has already granted orphan drug designation to XOMA 358, which is being assessed as a novel treatment for non-drug-induced, endogenous hyperinsulinemic hypoglycemia, as well as hypoglycemia after bariatric surgery.

Biotechnology firm XOMA recently started phase 2 studies in patients with CHI, and in patients with hypoglycemia post bariatric surgery.  

Patients are being enrolled at clinical sites in the US and European Union in phase 2 development for CHI.

XOMA senior vice president, research and development, and chief medical officer Paul Rubin  said: "Congenital hyperinsulinism is a devastating disease that presents in infancy and leads to profound hypoglycemia, which can cause significant morbidities, including brain damage, seizures and epilepsy.

“The EMA Orphan Drug Designation for CHI recognizes the significant unmet medical need for CHI patients, and is an important step in the development pathway for XOMA 358.”

XOMA discovers and develops therapeutic antibodies. The company's product candidates result from its experience in developing ground-breaking monoclonal antibodies, including allosteric antibodies.