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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:
N/A
Award ID:
Program Year/Program:
2012 / SBIR
Agency Tracking Number:
R44DK096706
Solicitation Year:
2012
Solicitation Topic Code:
NIDDK
Solicitation Number:
PA11-096
Small Business Information
XERIS PHARMACEUTICALS, INC.
3208 Red River Street Suite 300 Austin, TX 78705-
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2012
Title: Clinical Development of a Stable Glucagon Formulation for Bi-hormonal Pump
Agency: HHS
Contract: 1R44DK096706-01
Award Amount: $343,124.00
 

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 pump system 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.

Principal Investigator:

Steven Prestrelski
510-742-9700
stevep@xerispharma.com

Business Contact:

Yash Sabharwal
512-534-8340
yash@xerispharma.com
Small Business Information at Submission:

XERIS PHARMACEUTICALS, INC.
3925 West Braker Lane, 3rd Floor Austin, TX 78759-5316

EIN/Tax ID: 120335242
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No