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A Novel Glycosaminoglycan-Based Therapeutic for Chronic Rhinosinusitis

Award Number: R44AI126987
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2016
PERIOD OF PERFORMANCE END DATE: 05/31/2024

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A Novel Glycosaminoglycan-Based Therapeutic for Chronic Rhinosinusitis - 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).


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2022	GLYCOMIRA LLC	160 GREENTREE DR	DOVER	DE	19904	KENT	USA	Allergy and Infectious Diseases Research	000	6	5/22/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	GLYCOMIRA LLC	160 GREENTREE DR	DOVER	DE	19904	KENT	USA	Allergy and Infectious Diseases Research	000	6	1/17/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $976,018 )
2022	2022	GLYCOMIRA LLC	160 GREENTREE DR	DOVER	DE	19904	KENT	USA	Allergy and Infectious Diseases Research	000	6	5/17/2022	NON-COMPETING CONTINUATION	$976,018
														Subtotal = $976,018

Issue Date FY: 2021 ( Subtotal = $999,953 )
2021	2021	GLYCOMIRA, LLC	160 GREENTREE DR STE 101	DOVER	DE	19904	KENT	USA	Allergy and Infectious Diseases Research	001	5	6/24/2021	COMPETING CONTINUATION	$999,953
2021	2020	GLYCOMIRA, LLC	160 GREENTREE DR STE 101	DOVER	DE	19904	KENT	USA	Allergy and Infectious Diseases Research	000	4	6/24/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $999,953

Issue Date FY: 2020 ( Subtotal = $783,698 )
2020	2020	GLYCOMIRA, LLC	160 GREENTREE DR STE 101	DOVER	DE	19904	KENT	USA	Allergy and Infectious Diseases Research	000	4	1/30/2020	NON-COMPETING CONTINUATION	$783,698
														Subtotal = $783,698

Issue Date FY: 2019 ( Subtotal = $841,614 )
2019	2019	GLYCOMIRA, LLC	160 GREENTREE DR STE 101	DOVER	DE	19904	KENT	USA	Allergy and Infectious Diseases Research	000	3	1/28/2019	NON-COMPETING CONTINUATION	$841,614
														Subtotal = $841,614

Issue Date FY: 2018 ( Subtotal = $781,547 )
2018	2018	GLYCOMIRA, LLC	160 GREENTREE DR STE 101	DOVER	DE	19904	KENT	USA	Allergy and Infectious Diseases Research	000	2	2/5/2018	COMPETING CONTINUATION	$781,547
														Subtotal = $781,547

Grand Total All Awards = $4,382,830

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A Novel Glycosaminoglycan-Based Therapeutic for Chronic Rhinosinusitis

Award Number: R44AI126987

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/01/2016

PERIOD OF PERFORMANCE END DATE: 05/31/2024

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