Glucagon Mini-Dosing Pen for Treatment of Hypoglycemia

DESCRIPTION (provided by applicant): The program outlined in this application has been designed to accelerate the development and commercialization of a Glucagon Mini-Dose Pen to change the paradigm for treatment of moderate hypoglycemia in insulin-using diabetics. This research is directly relevant to the NIDDK which is explicitly interested in the development of innovative technologies for the prevention and treatment of hypoglycemia. The first objective of this program is to manufacture a batch of Xeris'non-aqueous glucagon rescue formulation in pre-filled syringes, which is room-temperature stable and does not require reconstitution. These clinical supplies will be put on a long-term stability study in preparation for conducting a Phase 2a clinical trial. The second objective of this program is to conduct a Phase 2a clinical study in healthy, type 1 diabetics that allows for patient-friendly administration of mini-doses of glucagon In this context, healthy refers to well controlled/managed insulin-usin