# Long-acting Stable Glucagons for Treatment of Hyperinsulinism

> **NIH NIH R44** · AMIDEBIO, LLC · 2022 · $1,287,693

## Abstract

SUMMARY/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 native
glucagon renders it inappropriate for chronic use in HI, and care-giver concerns about pump and
infusion-tube blockage for stable glucagon analogs creates both administration problems and
potential complications. In our redirected Phase II grant, we successfully discovered long-acting
solution stable glucagon analogs suitable for treating HI, which would eliminate these concerns. In
this Phase IIb project, we aim to further validate these lead analogs in HI mouse models, perform
large scale (gram level) GLP production of the lead candidates to support the necessary toxicology,
immunogenicity and formulation studies for an IND application. We also intend to pursue Orphan
Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) prior to IND submission.

## Key facts

- **NIH application ID:** 10611746
- **Project number:** 2R44DK111304-05
- **Recipient organization:** AMIDEBIO, LLC
- **Principal Investigator:** Pawel Fludzinski
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,287,693
- **Award type:** 2
- **Project period:** 2017-09-18 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10611746

## Citation

> US National Institutes of Health, RePORTER application 10611746, Long-acting Stable Glucagons for Treatment of Hyperinsulinism (2R44DK111304-05). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10611746. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*