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Treatment of NTM Respiratory Infections with Inhaled Drug Delivery

Award Number: R43AI132067
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: 02/06/2017
PERIOD OF PERFORMANCE END DATE: 07/31/2019

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Treatment of NTM Respiratory Infections with Inhaled Drug Delivery - Project Summary/Abstract (Description) Significance: Non-tuberculous mycobacteria (NTM) respiratory infections is increasing across the globe. In the US, in those over 65 years-old, annual prevalence of pulmonary NTM disease increased significantly from 20 to 47 cases/100,000 between 1997-2007 with Hawaii having the highest prevalence at 396 cases/100,000. Pulmonary NTM is 1.4 times more common in women. These numbers are likely underestimated because of a lack of mandatory reporting in the U.S. Treatment of non-tuberculous mycobacterial lung disease is challenging for several reasons including the relative resistance to currently available drugs and the difficulty in tolerating prolonged treatment with multiple drugs. The only oral drugs with reliable activity against M. abscessus complex an NTM are the macrolides and clofazimine. Similar to that for M. avium complex, clofazimine was found to synergize with clarithromycin or amikacin against M. abscessus Clofazimine is an attractive agent for treatment of NTM respiratory infections including M. abscessus but cutaneous and internal organ accumulation from high oral doses cause significant toxicity. High oral doses are required to reach effective concentrations in the lungs. Inhaled doses of clofazimine have the potential to reach immediate treatment concentrations in the lungs with inhaled low doses that do not have significant systemic toxicity. Preliminary Data: Aerophase has recently demonstrated that innovative aerosol formulations of clofazimine with a new type of aerosol drug inhaler can treat TB respiratory infections without side effects from systemic toxicity. The new clofazimine formulation and aerosol device has demonstrated sustained pulmonary treatment concentration and an aerosol size range that can target the entire lung with clofazimine even alveolar regions. The Aerophase inhaled aerosol delivery method holds great promise to mitigate toxicity and allow for safe clofazimine administration directly targeted to the site of infection. Specific Aims: The first aim of this project is to treat NTM respiratory infections with inhaled clofazimine much more effectively than oral clofazimine with much lower inhaled dose. The second aim is to develop a small pocket sized metered dose inhaler with drug formulation, aerosol size, and dose optimized to treat NTM respiratory infections. The third aim will test in-vivo efficacy of inhaled clofazimine in combination with other drugs.


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: 2020 ( Subtotal = $0 )
2020	2018	AEROPHASE INC	401 MOUNTAIN VIEW AVE	LONGMONT	CO	80501	BOULDER	USA	Allergy and Infectious Diseases Research	000	2	12/18/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $150,000 )
2018	2018	AEROPHASE INC	401 MOUNTAIN VIEW AVE	LONGMONT	CO	80501	BOULDER	USA	Allergy and Infectious Diseases Research	000	2	5/22/2018	NON-COMPETING CONTINUATION	$150,000
														Subtotal = $150,000

Issue Date FY: 2017 ( Subtotal = $300,000 )
2017	2017	AEROPHASE INC	401 MOUNTAIN VIEW AVE	LONGMONT	CO	80501	BOULDER	USA	Allergy and Infectious Diseases Research	000	1	2/6/2017	NEW	$300,000
														Subtotal = $300,000

Grand Total All Awards = $450,000

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Treatment of NTM Respiratory Infections with Inhaled Drug Delivery

Award Number: R43AI132067

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: 02/06/2017

PERIOD OF PERFORMANCE END DATE: 07/31/2019

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