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

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$713,733.00
Award Year:
2013
Program:
SBIR
Phase:
Phase II
Contract:
4R44DK096706-02
Award Id:
n/a
Agency Tracking Number:
R44DK096706
Solicitation Year:
2013
Solicitation Topic Code:
NIDDK
Solicitation Number:
PA11-096
Small Business Information
3208 Red River Street, Suite 300, Austin, TX, 78705-
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
609377135
Principal Investigator:
STEVEN PRESTRELSKI
(858) 414-1014
stevep@xerispharma.com
Business Contact:
YASH SABHARWAL
(512) 534-8340
yash@xerispharma.com
Research Institute:
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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