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Aerosol spectinamide-1599 therapy against tuberculosis

Award Number: R01AI120670
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: 06/10/2016
PERIOD OF PERFORMANCE END DATE: 12/31/2022

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Aerosol spectinamide-1599 therapy against tuberculosis - Summary The lengthy treatment for tuberculosis (TB) is the primary cause of the emergence of multidrug resistant tuberculosis (MDR-TB), as it frequently results in non-compliance. Current chemotherapy for MDR-TB can last up to two years with multidrug regimens some of which are painful injectable drugs with serious associated toxicity. Eradication and control of TB depends on the development of shorter and more effective treatment regimens with minimal drug associated toxicity. One approach under study in this application is to develop an inhalational TB therapy [to replace injectable drugs] that when administered with oral TB drugs eases and shortens treatment. Aerosolized drug delivery unlike injectable agents is easy to administer and provides high pulmonary concentrations of antibiotics to the local site of infection thereby reducing the systemic level of exposure to the drug. A recently published article in Nature Medicine by the “spectinamide consortium” showed that novel spectinamide analogs have excellent activity against Mycobacterium tuberculosis (Mtb) including MDR and XDR Mtb strains in vitro, as well as in vivo when administered by subcutaneous injection. In the same study, the lead compound spectinamide-1599 demonstrated strong efficacy against pulmonary TB when administered as a liquid formulation directly to the lungs of mice via intrapulmonary aerosol (IPA) delivery. By expanding on our preliminary data in this application Aim 1 will determine the pharmacokinetics (PK) and tissue distribution of spectinamide-1599 after IPA. Aim 2 will determine optimal dose, duration and frequency for treatment with spectinamide-1599 delivered by IPA and Aim3 will optimize a dry powder formulation of spectinamide-1599 to be used as inhalational TB therapy. These studies will be developed as a consortium between experts in the field of TB, inhalational animal models of TB and preclinical studies, pharmacokinetics and pharmacodynamics of TB chemotherapy and aerosol formulations and formulation of dry powders located at Colorado State University, University of Tennessee, Research Triangle Institute and St. Jude Children's Research Hospital. Working all together this consortium of researchers aims to advance research for this drug to the level that inhalational therapy via spectinamide-1599 can be considered a new drug/therapy candidate for TB. Thus, these studies will provide a formulation and inhalational therapy regimen of the spectinamide-1599 with well defined aerodynamic and PK properties and of well characterized in vivo efficacy for future testing in multidrug combination studies and in larger inhalational animal TB models and ultimately in TB patients.


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: 2024 ( Subtotal = $0 )
2024	2020	COLORADO STATE UNIVERSITY	601 S HOWES ST	FORT COLLINS	CO	80521	LARIMER	USA	Allergy and Infectious Diseases Research	000	5	10/24/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2020	COLORADO STATE UNIVERSITY	601 S HOWES ST	FORT COLLINS	CO	80521	LARIMER	USA	Allergy and Infectious Diseases Research	000	5	5/23/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $710,674 )
2020	2020	COLORADO STATE UNIVERSITY	601 S HOWES ST	FORT COLLINS	CO	80521	LARIMER	USA	Allergy and Infectious Diseases Research	000	5	5/21/2020	NON-COMPETING CONTINUATION	$710,674
														Subtotal = $710,674

Issue Date FY: 2019 ( Subtotal = $729,832 )
2019	2019	COLORADO STATE UNIVERSITY	601 S HOWES ST	FORT COLLINS	CO	80521	LARIMER	USA	Allergy and Infectious Diseases Research	000	4	6/7/2019	NON-COMPETING CONTINUATION	$729,832
														Subtotal = $729,832

Issue Date FY: 2018 ( Subtotal = $668,501 )
2018	2018	COLORADO STATE UNIVERSITY	601 S HOWES ST	FORT COLLINS	CO	80521	LARIMER	USA	Allergy and Infectious Diseases Research	000	3	5/17/2018	NON-COMPETING CONTINUATION	$668,501
														Subtotal = $668,501

Issue Date FY: 2017 ( Subtotal = $848,545 )
2017	2017	COLORADO STATE UNIVERSITY	601 S HOWES ST	FORT COLLINS	CO	80521	LARIMER	USA	Allergy and Infectious Diseases Research	001	2	8/11/2017	NON-COMPETING CONTINUATION	$177,188
2017	2017	COLORADO STATE UNIVERSITY	601 S HOWES ST	FORT COLLINS	CO	80521	LARIMER	USA	Allergy and Infectious Diseases Research	000	2	5/1/2017	NON-COMPETING CONTINUATION	$671,357
														Subtotal = $848,545

Issue Date FY: 2016 ( Subtotal = $629,894 )
2016	2016	COLORADO STATE UNIVERSITY	UNIV SERVICES CENTER, ROOM 408	FORT COLLINS	CO	805232002	LARIMER	USA	Allergy and Infectious Diseases Research	001	1	6/22/2016	NEW	$0
2016	2016	COLORADO STATE UNIVERSITY	UNIV SERVICES CENTER, ROOM 408	FORT COLLINS	CO	80523	LARIMER	USA	Allergy and Infectious Diseases Research	000	1	6/10/2016	NEW	$629,894
														Subtotal = $629,894

Grand Total All Awards = $3,587,446

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Aerosol spectinamide-1599 therapy against tuberculosis

Award Number: R01AI120670

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: 06/10/2016

PERIOD OF PERFORMANCE END DATE: 12/31/2022

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