# A Novel Glycosaminoglycan-Based Therapeutic for Chronic Rhinosinusitis

> **NIH NIH R44** · GLYCOMIRA, LLC · 2021 · $999,953

## Abstract

PROJECT SUMMARY
Chronic rhinosinusitis (CRS) is one of the most prevalent inflammatory diseases in the U.S., affecting up to
12% of the population and substantially diminishing the quality of life and productivity of patients. In four years,
the annual U.S. health care expenditure to treat patients with CRS increased from $9B to $64B, with a
corresponding rise in surgical treatment for those 20% of patients who fail medical management with the first
line of defense – saline nasal irrigation and corticosteroid nasal sprays. Recently approved or emerging
technologies for CRS continue to rely on corticosteroid treatment with new delivery methods. However, safety
concerns over the long-term use of corticosteroids still remain, and the end result continues to be inadequate
control of the disease. GlycoMira Therapeutics’ GM-1111 is a synthetic glycosaminoglycan-based drug
candidate that targets innate immunity molecules Toll-like receptor 2 and 4 to reduce downstream
inflammatory consequences, such as the production of inflammatory cytokines and influx of inflammatory
immune cells into damaged tissues. In models of CRS, intra-nasal administration of GM-1111 outcompetes
corticosteroids as an effective treatment for reducing sinonasal inflammation, with significantly decreased
inflammatory cytokine production, leukocyte infiltration, mucus accumulation, and air-sinonasal epithelial cell
barrier breakdown/impaired mucociliary clearance. Studies have additionally demonstrated that GM-1111 is
safe and stable when administered in a wide range of formulations and doses. In this Phase IIB proposal, GM-
1111 will be further developed as a new therapeutic for the effective treatment of CRS. The overall goal is to
advance GM-1111 to an Investigational New Drug (IND) application filing and human clinical trials, which will
be accomplished through the completion of IND-enabling safety/toxicology studies in two animal species (Aim
1), GM-1111 drug product stability testing for clinical trial use, and IND application submission (Aim 2).

## Key facts

- **NIH application ID:** 10323966
- **Project number:** 2R44AI126987-05A1
- **Recipient organization:** GLYCOMIRA, LLC
- **Principal Investigator:** Abigail Pulsipher
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $999,953
- **Award type:** 2
- **Project period:** 2016-08-01 → 2023-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10323966

## Citation

> US National Institutes of Health, RePORTER application 10323966, A Novel Glycosaminoglycan-Based Therapeutic for Chronic Rhinosinusitis (2R44AI126987-05A1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10323966. Licensed CC0.

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