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Development of NH101: A Simple and Efficient Outpatient Dry Powder Amphotericin B-DryNeb(dry powder nebulizer) for Treatment of Susceptible and Multidrug Resistant Aspergillus/ Fungal Infections

Award Number: R44HL147749
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/15/2020
PERIOD OF PERFORMANCE END DATE: 06/30/2024

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Development of NH101: A Simple and Efficient Outpatient Dry Powder Amphotericin B-DryNeb(dry powder nebulizer) for Treatment of Susceptible and Multidrug Resistant Aspergillus/ Fungal Infections - Project Summary The overall objective of this project is to build on the successes of our Phase I SBIR studies to progress NH101: a pure (neat) dry powder of amphotericin B (AMB) combined with the DryNeb™, a novel dry powder nebulizer to “clinic ready” status. The results of this program will enable a Phase I clinical study (AUS), engagement with the FDA on the NH101 505(b)(2) regulatory approval pathway, and ultimately, an Investigational New Drug (IND) application and Phase II clinical proof of concept (POC) efficacy testing in Allergic Bronchopulmonary Aspergillosis (ABPA). NH101 (AMB-DryNeb™) satisfies multiple unmet medical needs by targeting common and triazole (antifungal classes, e.g., itraconazole) multidrug resistant (MDR) strains of aspergillus at the site of lung infection. NH101 will initially focus on cystic fibrosis (CF) and asthma-associated ABPA, a rare, orphan and severe disease of unmet medical need commonly associated with an estimated 2.5% of asthmatics (~5 million) and 15% (~20,000) of CF patients. This project will achieve three primary objectives: 1) refine, test, and produce the DryNeb™ to clinical-grade scale, 2) scale up and formulate AMB at Kg scale, and 3) perform a first in human-enabling repeat dose GLP toxicology study.


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	2023	NOB HILL THERAPEUTICS, INC.	5901 INDIAN SCHOOL RD NE	ALBUQUERQUE	NM	87110	BERNALILLO	USA	Lung Diseases Research	000	3	12/9/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $564,303 )
2023	2023	NOB HILL THERAPEUTICS INC	5901 INDIAN SCHOOL RD NE	ALBUQUERQUE	NM	87110	BERNALILLO	USA	Lung Diseases Research	000	3	6/19/2023	NON-COMPETING CONTINUATION	$564,303
														Subtotal = $564,303

Issue Date FY: 2022 ( Subtotal = $1,158,273 )
2022	2022	NOB HILL THERAPEUTICS, INC.	5901 INDIAN SCHOOL RD NE UNIT 209	ALBUQUERQUE	NM	87110	BERNALILLO	USA	Lung Diseases Research	000	2	6/28/2022	COMPETING CONTINUATION	$1,158,273
														Subtotal = $1,158,273

Grand Total All Awards = $1,722,576

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Development of NH101: A Simple and Efficient Outpatient Dry Powder Amphotericin B-DryNeb(dry powder nebulizer) for Treatment of Susceptible and Multidrug Resistant Aspergillus/ Fungal Infections

Award Number: R44HL147749

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 02/15/2020

PERIOD OF PERFORMANCE END DATE: 06/30/2024

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