Improved Hypoglycemia Rescue Device

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 2R44DK085809-02
Agency Tracking Number: R44DK085809
Amount: $994,123.00
Phase: Phase II
Program: SBIR
Awards Year: 2011
Solicitation Year: 2011
Solicitation Topic Code: NIDDK
Solicitation Number: PA10-050
Small Business Information
3925 West Braker Lane, 3rd Floor, Austin, TX, 78759-5316
DUNS: 609377135
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (415) 472-4623
Business Contact
Phone: (415) 472-4623
Research Institution
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) Fullenrollment 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 thesebenchmarks 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 reconstitutethe 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 911calls and emergency room visits.

* Information listed above is at the time of submission. *

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