The FDA granted Crinetics Pharmaceuticals’ (NASDAQ:CRNX) CRN04777 rare pediatric disease designation for the treatment of congenital hyperinsulinism.
Congenital hyperinsulinism occurs when infants are born with life-threatening hypoglycemia due to excess insulin secretion.
“Failure to recognize and effectively treat this disease can lead to seizures, permanent neurological sequelae, and even death,” Dr. Christine Ferrara-Cook, Crinetics’ medical director, said in a statement.
“CRN04777 is the first oral, selective nonpeptide somatostatin receptor type 5 receptor agonist designed to reduce insulin secretion and is intended to be a universal treatment for all patients with congenital hyperinsulinism,” she added.
Crinetics plans to launch a Phase 1 study of CRN04777 for the treatment of congenital hyperinsulinism in early 2021.