Eiger BioPharmaceuticals (EIGR) Receives EMA Orphan Designation for Exendin 9-39 as NIPHS Treatment

October 17, 2016 8:07 AM EDT
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Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR) announced that the European Medicines Agency (EMA) has granted orphan designation to exendin 9-39 for the treatment of non-insulinoma pancreatogenous hypoglycemia syndrome (NIPHS). NIPHS describes a spectrum of acquired metabolic disorders characterized by inappropriately high insulin levels (hyperinsulinemia) and low blood glucose levels (hypoglycemia), which includes post-bariatric hypoglycemia (PBH). Eiger is developing a novel subcutaneously administered form of exendin 9-39 for patients who experience dangerously low postprandial (postmeal) blood glucose levels due to PBH, a rare and debilitating disorder with no approved treatment.

"Stanford researchers have demonstrated activity in two separate clinical proof-of-concept studies, first using an intravenous infusion of exendin 9-39 and more recently using subcutaneous injection of exendin 9-39 in patients with PBH. Exendin 9-39 prevented hypoglycemia and associated symptoms during oral glucose tolerance testing in patients with PBH," said David Cory, President and CEO of Eiger. "A significant unmet medical need exists and exendin 9-39 represents the first potential targeted therapy for patients suffering from PBH. A phase 2 multiple ascending dose (MAD) study of subcutaneously injected exendin 9-39 in PBH patients is currently enrolling at Stanford and we look forward to reporting results."

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