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XOMA Corporation (NASDAQ:XOMA) has initiated a Phase 2 proof-of-concept study evaluating the safety and ability to prevent hypoglycemia of a single dose of XOMA 358 in patients with congenital hyperinsulinism (HI).
XOMA Corporation (NASDAQ:XOMA) has initiated a Phase 2 proof-of-concept study evaluating the safety and ability to prevent hypoglycemia of a single dose of XOMA 358 in patients with congenital hyperinsulinism (HI).
According to the press release:
XOMA 358 is a fully human allosteric monoclonal antibody that reduces insulin receptor activity.
HI is a genetic disorder in which the beta cells of the pancreas secrete excessive insulin that causes hypoglycemia, which can lead to brain damage or, in rare cases, death. HI is a rare disease, affecting approximately 1 in 50,000 newborns. TheU.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to XOMA 358 for the treatment of HI.
“New treatments that safely and effectively attenuate insulin-induced hypoglycemia are needed for patients with congenital hyperinsulinism, as well as other diseases that cause hypoglycemia due to high insulin levels. There are no approved medications, and those currently used have inconsistent efficacy and issues with tolerability. Current disease management options are limited to continuous ingestion or infusion of glucose or surgical removal of part or all of the pancreas,” said Paul Rubin, M.D., Senior Vice President, Research and Development, and Chief Medical Officer at XOMA. “We are developingXOMA 358 as a first-in-class therapeutic for patients with this potentially fatal disease, and we are pleased to be conducting this study at a world-class medical center recognized for its leadership in treating HI patients.”
Click here to read the full press release.