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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: 2R44AI126987-05A1
Agency Tracking Number: R44AI126987
Amount: $1,975,971.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA20-260
Solicitation Year: 2020
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-06-24
Award End Date (Contract End Date): 2023-05-31
Small Business Information
Dover, DE 19904-7620
United States
DUNS: 827444345
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (801) 649-3999
Business Contact
Phone: (801) 295-5483
Research Institution

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).

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

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