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Clinical Development of a Stable Glucagon Formulation for Bi-hormonal Pump

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R44DK096706-02
Agency Tracking Number: R44DK096706
Amount: $713,733.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIDDK
Solicitation Number: PA11-096
Timeline
Solicitation Year: 2013
Award Year: 2013
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
3208 Red River Street Suite 300
Austin, TX 78705-
United States
DUNS: 609377135
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 STEVEN PRESTRELSKI
 (858) 414-1014
 stevep@xerispharma.com
Business Contact
 YASH SABHARWAL
Phone: (512) 534-8340
Email: yash@xerispharma.com
Research Institution
 Stub
Abstract

DESCRIPTION (provided by applicant): The objective of this program is to further the development of a novel, stable, non-aqueous glucagon formulation as an integral component of a bi-hormonal (insulin-glucagon) pump system for treatment of persons with diabetes. The addition of glucagon to the present insulin-based systems will allow greater control of blood glucose with a lower risk of hypoglycemia. The primary objective of the current proposal is directly relevant to an NIDDK research priority, the development of improved delivery systems for the artificial pancreas. This program intends to demonstrate the safety, pharmacokinetics and pharmacodynamics of this novel glucagon formulation in animals and in type 1 diabetics. The major clinical metric for thisstudy will be the capacity of this glucagon formulation to raise glucose levels even after short-term aging in a patch pump chamber. The initial effort of this project will develop and optimize a non-aqueous, liquid glucagon formulation designed for the bi-hormonal pump application, demonstrate its safety, and characterize its pharmacology in preclinical models. The second effort will take the optimized formulation into a clinical supplies manufacturing program. The manufacturing program will produce supplies for the clinical trial in a GMP facility and include shelf-life and 'in-use' stability testing. This effort also includes assessment of the safety, pharmacokinetics and preliminary efficacy (glucodynamics) of the non-aqueous, glucagon solution in a pumpsystem in a Phase 1 clinical trial in type 1 diabetics. PUBLIC HEALTH RELEVANCE The objective of this program is to further the development of a novel, stable, non-aqueous glucagon formulation as an integral component of a bi-hormonal (insulin-glucagon) pump system for treatment of persons with diabetes. The addition of a glucagon component to the present insulin-based systems will allow greater control of blood glucose with a lower risk of hypoglycemia.

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

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