# Stable Glucagon for Treatment of Hyperinsulinism

> **NIH NIH R44** · AMIDEBIO, LLC · 2020 · $816,607

## Abstract

In severe persistent hyperinsulinism (HI), repeated hypoglycemic episodes can ultimately lead to
permanent seizure disorders, learning disabilities, cerebral palsy, blindness and even death. Clinical
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 costs. However, the instability of glucagon in
solution creates both administration problems and potential complications due to infusion tube
blockage. These instability problems have limited the use of glucagon for severe persistent HI. To
overcome this problem, in 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 vivo. These analogs when formulated in a conventional sterile diluent maintain not only the
standard 95% potency requirement throughout a 2 year storage period at 4ºC but more importantly
offer an extended “in use” stability period of at least 3 months at 40ºC. Such 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 issues. In addition, such a
product will be suitable for emergency hypoglycemic incidences which result in over 200,000
hospitalizations a year. Finally, the resultant product could be implemented in a bi-hormonal artificial
pancreas for T1 and T2 diabetes. In this Phase II project, we aim to develop large scale (gram level)
GLP production of the lead candidates, complete toxicology, immunogenicity and formulation studies,
and prepare a regulatory package suitable for filing an IND in preparation for clinical trials.

## Key facts

- **NIH application ID:** 10017955
- **Project number:** 5R44DK111304-04
- **Recipient organization:** AMIDEBIO, LLC
- **Principal Investigator:** Pawel Fludzinski
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $816,607
- **Award type:** 5
- **Project period:** 2017-09-18 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10017955

## Citation

> US National Institutes of Health, RePORTER application 10017955, Stable Glucagon for Treatment of Hyperinsulinism (5R44DK111304-04). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10017955. Licensed CC0.

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