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A Novel Glycosaminoglycan-Based Therapeutic for Chronic Rhinosinusitis

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44AI126987-02
Agency Tracking Number: R44AI126987
Amount: $2,406,859.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA17-302
Timeline
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-02-06
Award End Date (Contract End Date): 2021-01-31
Small Business Information
160 GREENTREE DR STE 101
Dover, DE 19904-7620
United States
DUNS: 827444345
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 ABIGAIL PULSIPHER
 (434) 249-3268
 abbypulsipher@gmail.com
Business Contact
 GRANT HEATH
Phone: (801) 649-3999
Email: gtheath@gmail.com
Research Institution
N/A
Abstract

PROJECT SUMMARY
Chronic rhinosinusitis (CRS) is one of the most prevalent inflammatory diseases in the U.S., affecting up to
16% 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 dramatically increased from $9B to $64B
(5% of the health care budget), with a corresponding rise in surgical treatment for those 20% of patients who
fail current medical management. Despite these staggering statistics, CRS remains an under-researched
epidemic with limited effective treatment options. GlycoMira’s lead candidate, GM-1111, is a synthetic
glycosaminoglycan that inhibits multiple inflammatory mediators and more specifically, targets Toll-like receptor
2-mediated signaling. Moreover, topical intranasal administration of GM-1111 effectively reduces chronic
sinonasal inflammation in mice. Animals treated with GM-1111 showed significant reductions in degenerative
histologic changes, inflammatory cell infiltration, goblet cell hyperplasia, and cytokine gene expression within
the sinonasal tissues. Herein, GM-1111 will be further developed and validated as a commercially viable and
effective therapy for CRS. In Aim 1, the optimal dosing regimen and degree to which GM-1111 effectively
treats CRS will be determined by testing a wide range of doses and dosing frequencies in animal models of
CRS. The efficacy of GM-1111 will be compared to healthy, inflammatory, and therapeutic controls by
analyzing the clinical signs, histologic changes, and inflammatory tissue biomarkers associated with CRS. In
Aim 2, the potential mucolytic properties of GM-1111 will be investigated, and the effect of GM-1111 on ciliary
function will be determined. Increased mucus production and impaired mucociliary clearance are central to the
pathogenesis of CRS and elevate the risk of opportunistic pathogen infection. Based on mechanistic evidence
with a similar glycosaminoglycan, topically administered GM-1111 should penetrate mucus and reduce
sinonasal inflammation. To test this hypothesis, the effects of GM-1111 on artificial mucus with known mucin
and bacterial composition, nasal secretions from patients with CRS, and ciliary function using sinonasal tissue
from controls and patients with CRS will be investigated. The efficiency of GM-1111 to penetrate mucus and
tissue to effectively reduce sinonasal inflammation will then be determined in an animal model of CRS
characterized by a robust mucus response. These studies will provide crucial preclinical data supporting GM-
1111 as a commercially viable and effective therapeutic for treating the millions of patients affected by this
debilitating disease.PROJECT NARRATIVE
GlycoMira Therapeutics is developing an effective treatment for chronic rhinosinusitis, a debilitating
inflammatory disease that substantially diminishes the quality of life and productivity of up to 16% of the U.S.
population and requires $64B annually in direct costs to treat patients. Currently available therapies fail to help
20% of patients with chronic rhinosinusitis, underscoring the dire need for new therapeutics that can improve
the lives of millions of Americans.

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

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