Xeris Pharmaceuticals gets new ODD from the USFDA

Xeris Pharmaceuticals got its third orphane drug designation from the USFDA, this time for its treatment of Hyperinsulinemic Hypoglycemia.

Xeris also said on Thursday, beside getting the PDD for the liquid-stable glucagon for Hyperinsulinemic Hypoglycemia (HH), it has published a Phase 2a study of a mini-dose of its ready-to-use glucagon in Post-Bariatric Hypoglycemia (PBH).

HH describes a condition in which a person’s blood glucose levels become low, or hypoglycemic, due to excessive insulin secretion.  ODD approval was given, in part, on the basis that mini-doses of Xeris’ ready-to-use glucagon may be more safe than similar drugs already approved.

HH is associated with several diseases, including Post-Bariatric Hypoglycemia (PBH).  Today, there is no approved therapy for the treatment of PBH.

“Hypoglycemia can be a devastating complication of bariatric surgery. There is an urgent need for improved methods to treat severe hypoglycemia in this condition in order to maintain health, allow optimal nutrition, and improve safety.  Having a ready-to-use, liquid, stable glucagon option may provide health care professionals and patients alike more options to treat and prevent severe hypoglycemia,” said Mary-Elizabeth Patti, F.A.C.P. of the Joslin Diabetes Center and Associate Professor of Medicine, Harvard Medical School.

The results of a Phase 2a study (NCT02733588) to validate the ability to successfully treat people with PBH with mini-doses of Xeris’ ready-to-use glucagon, was published last week in the journal Diabetes Technology & Therapeutics. The study confirmed that mini-doses of Xeris’ ready-to-use glucagon at specific blood glucose thresholds prevented severe hypoglycemia, with no rebound hyperglycemia.

“This combination of emerging technology and stable liquid glucagon can provide a new way to prevent severe hypoglycemia as we demonstrate in this study and may pave the way to be the ‘airbag’ for people with diabetes.” said Dr. Dassau.

FDA previously granted Xeris ODDs for both its ready-to-use, pumpable liquid-stable glucagon for prevention of chronic, severe hypoglycemia related to Congenital Hyperinsulinism (CHI), as well as for a ready-to-use, liquid-stable formulation of diazepam for the treatment of Acute Repetitive Seizures (ARS) in patients with epilepsy.