XOMA Corp. (XOMA) said it has successfully established proof of concept and initial safety for its drug candidate XOMA-358 to treat congenital hyperinsulinism and hypoglycemia post-bariatric surgery. The success paves the way for XOMA to proceed with the evaluation of the therapy’s consistency and magnitude in the target patient population. (For more, see XOMA Reports Success in Insulin Trials.)
The company soon plans to initiate a multi-dose study in children with congenital hyperinsulinism in the United Kingdom. With a single-dose getting completed and successfully meeting its objectives for hypoglycemia post-bariatric surgery, a multi-dose study has been initiated. (For more, see Xoma's Pediatric Insulin Study Gets UK OK.)
Congenital hyperinsulinism (CHI) is a rare disease which results in the over-production of insulin during early life. Insulin regulates blood sugar, and an unusual rise in insulin can cause severe problems such as brain damage, epilepsy, seizures and even death.
XOMA’s Potential CHI and PBS Therapy
Derived from XOMA’s proprietary XMet platform, XOMA-358 is a type of insulin receptor antibody. It works by blocking the insulin signaling by binding to the insulin receptor. The drug has secured orphan drug status for treating congenital hyperinsulinism in the U.S. and the EU.
XOMA-358 is being developed as a potential treatment for low blood glucose (hypoglycemia) caused by excessive insulin production (hyperinsulinemic hypoglycemia), and for hypoglycemia after bariatric surgery, which is an obesity treatment. Around 5% of the 67,000 patients that undergo the Roux-en-Y method of bariatric surgery are estimated to develop severe hypoglycemia.
"With the large unmet clinical need in patients with CHI and PBS, 358 provides a first-in-class antibody with the potential to help pediatric and adult patients properly regulate their blood glucose concentrations and prevent hypoglycemic episodes," said Dr. Eric P. Brass, professor emeritus at UCLA's David Geffen School of Medicine. (See also, Xoma Declares 1-for-20 Reverse Stock Split.)