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Harnessing bacteriophages as natural predators to combat the superbugs: a pulmonary drug delivery approach

Award Number: R33AI121627
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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DESCRIPTION (provided by applicant): As highlighted in the 'Bad Bugs, No Drugs' campaign by the Infectious Diseases Society of America (IDSA), "There simply aren't enough new drugs in the pharmaceutical pipeline to keep pace with drug resistant bacterial infections, so-called `superbugs'." Numerous hospitals worldwide have experienced outbreaks of infections caused by multidrug-resistant (MDR) Pseudomonas aeruginosa, one of the six top-priority dangerous "ESKAPE" microorganisms identified by the IDSA that require the most urgent attention to discover new antibiotics. Sadly, no novel antibiotics against MDR P. aeruginosa will be available for many years to come. Polymyxins (i.e. colistin and polymyxin B) are now being used as the `last-line' of therapy for infections caused by these very problematic MDR pathogens. Most unfortunately, the emergence of polymyxin resistance has been increasingly reported recently. In essence, resistance to polymyxins implies a total lack of antibiotics for treatment of life-threatening infections caused by these Gram-negative bacteria. Research Design: Our research strategy includes R21 and R33 phases. The overall objective of this project is to harness inhaled bacteriophages as natural predators to combat the superbugs in respiratory infections. Our over-arching hypothesis is that inhalation delivery of phages as an aerosol will provide a safe and efficacious local treatment for MDR infections in the lungs. R21 phase includes two Specific Aims: (1) to produce novel phage powder formulations for inhalation aerosol delivery to the lungs, and (2) to establish the validity and utility of these phge formulations by physicochemical characterization and proof-of- concept efficacy study. If the specific milestones in R21 phase are met, the R33 phase will (1) elucidate the mechanism responsible for stabilization of phages in powder formulations, and evaluate the storage stability of the phage inhalation formulations [Specific Aim 3], and in parallel, examine the pharmacokinetics and potential toxicity of inhaled phage formulations [Specific Aim 4]. Finally, in vivo efficacy studies of inhaled phage formulations will be conducted using animal infection models [Specific Aim 5]. Together, these studies will identify the best phage formulation (plus one backup) for further pre-clinical pharmacological evaluations. As phages are already used clinically, there is great potential to rapidly translate our research findings to the clinic. Significance: This project holds great promise for the development of a novel phage therapy for respiratory infections caused by MDR P. aeruginosa. Our inter-disciplinary approach will provide the fastest track and cost effective clinical solutions for inhaled phage therapy to combat the very problematic Gram-negative `superbug'. Overall, this project targets an urgent global unmet medical need and it aligns perfectly with the 2014 NIAID Antimicrobial Resistance Research Strategic Approaches.


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: 2021 ( Subtotal = $0 )
2021	2020	UNIVERSITY OF SYDNEY	LEVEL 3, ADMINISTRATION BUILDING F23	THE UNIVERSITY OF SYDNEY	NSW			AUS	Allergy and Infectious Diseases Research	000	5	9/9/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $210,844 )
2020	2020	UNIVERSITY OF SYDNEY	LEVEL 3, ADMINISTRATION BUILDING F23	THE UNIVERSITY OF SYDNEY	NSW	2006		AUS	Allergy and Infectious Diseases Research	000	5	11/29/2019	NON-COMPETING CONTINUATION	$210,844
														Subtotal = $210,844

Issue Date FY: 2019 ( Subtotal = $228,194 )
2019	2019	UNIVERSITY OF SYDNEY	L3 K07 MARGARET TELFER BUILDING	THE UNIVERSITY OF SYDNEY	NSW	2006		AUS	Allergy and Infectious Diseases Research	000	4	11/7/2018	NON-COMPETING CONTINUATION	$228,194
														Subtotal = $228,194

Issue Date FY: 2018 ( Subtotal = $159,208 )
2018	2018	UNIVERSITY OF SYDNEY	L3 K07 MARGARET TELFER BUILDING	THE UNIVERSITY OF SYDNEY	NSW	2006		AUS	Allergy and Infectious Diseases Research	002	3	4/5/2018	EXTENSION WITH OR WITHOUT FUNDS	$0
2018	2018	UNIVERSITY OF SYDNEY	L 3 K07 MARGARET TELFER BUILDING	THE UNIVERSITY OF SYDNEY	NSW	2006		AUS	Allergy and Infectious Diseases Research	001	3	1/9/2018	EXTENSION WITH OR WITHOUT FUNDS	$0
2018	2018	UNIVERSITY OF SYDNEY	L 3 K07 MARGARET TELFER BUILDING	THE UNIVERSITY OF SYDNEY	NSW	2006		AUS	Allergy and Infectious Diseases Research	000	3	12/23/2017	EXTENSION WITH OR WITHOUT FUNDS	$159,208
														Subtotal = $159,208

Grand Total All Awards = $598,246

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Harnessing bacteriophages as natural predators to combat the superbugs: a pulmonary drug delivery approach

Award Number: R33AI121627

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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