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Stable Glucagon for Treatment of Hyperinsulinism

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44DK111304-03
Agency Tracking Number: R44DK111304
Amount: $740,140.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 200
Solicitation Number: PA18-574
Timeline
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-09-13
Award End Date (Contract End Date): 2021-08-31
Small Business Information
2830 13 ST., Boulder, CO, 80304-3518
DUNS: 831649236
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 PAWEL FLUDZINSKI
 (303) 604-0296
 pawel.fludzinski@amidebio.com
Business Contact
 PAWEL FLUDZINSKI
Phone: (303) 604-0296
Email: pawel.fludzinski@amidebio.com
Research Institution
N/A
Abstract
In severe persistent hyperinsulinismHIrepeated hypoglycemic episodes can ultimately lead to permanent seizure disorderslearning disabilitiescerebral palsyblindness and even deathClinical studies have demonstrated the effectiveness of both short term and long term treatment with glucagon for severe forms of HI and continuous subcutaneous administration of glucagon has been recommended both because of the potential improvement in patient outcome and high costs of surgical intervention followed by long term annual care costsHoweverthe instability of glucagon in solution creates both administration problems and potential complications due to infusion tube blockageThese instability problems have limited the use of glucagon for severe persistent HITo overcome this problemin our successful Phase I grant we developed a series of solution stable glucagon analogs using a novel design approach and demonstrated their effectiveness both in vitro and in vivoThese analogs when formulated in a conventional sterile diluent maintain not only the standardpotency requirement throughout ayear storage period atC but more importantly offer an extendedin usestability period of at leastmonths atCSuch analogs are compatible with implementation in a pump system for the long term management of severe persistent HI without concern for complications due to glucagon instability and pump clogging issuesIn additionsuch a product will be suitable for emergency hypoglycemic incidences which result in overhospitalizations a yearFinallythe resultant product could be implemented in a bi hormonal artificial pancreas for Tand TdiabetesIn this Phase II projectwe aim to develop large scalegram levelGLP production of the lead candidatescomplete toxicologyimmunogenicity and formulation studiesand prepare a regulatory package suitable for filing an IND in preparation for clinical trials In our successful Phase I granta series of novel glucagon analogues were designedproduced at milligram levelstested for solution stability and for both in vitro and in vivo activityWe have identifiedlead candidates with superior physical properties and biological activity in vivo using a hyperinsulinism modelIn this Phase II proposal we aim to complete large scalegram levelGLP production of the lead candidatescomplete toxicology and formulation studiesand prepare a regulatory package suitable for filing an IND in preparation for clinical trials aimed to demonstrate the use of our stable glucagon analogs for treating congenital hyperinsulinismemergency hypoglycemia and ultimately for treating Tand Tdiabetics using a bi hormonal pump

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

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