Improved Hypoglycemia Rescue Device

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DESCRIPTION (provided by applicant): The objective of this project is to demonstrate the safety, pharmacokinetics and initial efficacy of a ready-to-use Glucagon Rescue Pen that will deliver a very low volume dose of a glucagon without reconstitution for hypoglycemic emergencies. To execute on this objective, it is necessary to first finalize the concentrated non-aqueous glucagon solution developed in the Phase 1 program and thereafter, manufacture cGMP clinical supplies of the glucagon pen for the Phase 1-2 trial. The final phase in this program will be to conduct a Phase 1-2 clinical trial that will study the safety, pharmacokinetics and preliminary efficacy of the Glucagon Rescue Pen. If successful, these experiments will demonstrate the safety and initial effectiveness of a simple, portable, glucagon delivery system to support an NDA-enabling Phase 3 (bioequivalency) study. The first Specific Aim of this proposed project is to optimize the non-aqueous glucagon formulation and produce cGMP clinical supplies in a pre-filled auto-injection pen. The second Specific Aim is to file IND documentation and get FDA approval for a Phase 1-2 clinical plan. The Third Specific Aim will be to conduct a Phase 1-2 clinical trial with the Glucagon Rescue Pen. Success Benchmarks will include: 1) rapid identification of non-aqueous glucagon formulation; 2) manufacture of GMP clinical supplies of the autoinjector pen that can proceed into long and accelerated stability testing and release for use in the clinical trial; 3) Full enrollment of the Phase 1-2 clinical study that demonstrates the product's safety; pharmacokinetic profile (plasma glucagon levels) and a pharmacodynamic profile (blood glucose levels) that are equivalent to an aqueous-reconstituted glucagon. Meeting these benchmarks will justify advancing the product into an NDA-enabling bioequivalency study.