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.

Public Health Relevance

The current standard of care for hypoglycemic emergencies?the Glucagon Emergency Kit requires a diabetic's caregiver to reconstitute the peptide powder contained in a vial using a 1 mL prefilled syringe and to assure complete solubilization prior to injection. A patient friendly, ready---to---use auto---injector Glucagon Pen will reduce caregiver and patient fear and risk, costs of 911 calls and emergency room visits.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44DK085809-02
Application #
8203897
Study Section
Special Emphasis Panel (ZRG1-EMNR-E (10))
Program Officer
Arreaza-Rubin, Guillermo
Project Start
2009-09-30
Project End
2013-08-31
Budget Start
2011-09-20
Budget End
2012-08-31
Support Year
2
Fiscal Year
2011
Total Cost
$417,632
Indirect Cost
Name
Xeris Pharmaceuticals, Inc.
Department
Type
DUNS #
609377135
City
Austin
State
TX
Country
United States
Zip Code
78705