Official websites use .gov

A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS

A lock ( 🔒 ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

Need Help

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: R43HL147749
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: 07/31/2021

Group Awards By:

View Award Description

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 - The overall objective of this project is to progress NH01, a pure (neat) dry powder of amphotericin B (AMB) combined with our novel, simple to use, DryNeb™, dry powder nebulizer, through proof of principle pulmonary delivery, efficacy, pharmacokinetics (PK), and device-formulation characterization. The results of this program will be a decision gate for follow-on Investigational New Drug (IND)-enabling toxicology and device refinement funded through Phase II SBIR and other sources. NH101 (AMB-DryNeb™) satisfies an unmet medical need by targeting common and triazole (antifungal classes, e.g., itraconazole) multidrug resistant (MDR) strains of pulmonary-infecting fungi (including aspergillus species) at the site of lung infection. NH101 will initially focus on cystic fibrosis (CF) and asthma-associated allergic bronchopulmonary aspergillosis (ABPA), a rare, orphan, and severe subset of aspergillosis that causes severe allergic exacerbations and bronchiectasis. ABPA is associated with an estimated 2.5% of asthmatics (~5 million) and 15% (~20,000) of CF patients. Exciting proof of principle results have been generated in many “off label” studies of aerosolized IV formulations of AMB targeted at fungal lung disease including ABPA. However, there are currently no regulatory-approved aerosol therapies indicated for fungal infections/ diseases in the lung. For this project AMB will be formulated as a simple, neat, micronized/milled dry powder using standard techniques (i.e. jet mills, ball mills, etc.) with our established partners at Lonza. The latter avoids the need for blending, non-traditional excipients, and advanced technical expertise associated with carrier- based and spray-dried dry powder formulations. AMB will be delivered clinically by the DryNeb™ (US 9078985) developed by Dr. Hugh D. Smyth (Project Consultant) and exclusively licensed to Nob Hill Therapeutics (NHT). The DryNeb combines the high-dose capacity and easy tidal breathing of an on-demand nebulizer with the portability and stability characteristics of a dry powder inhaler. The AMB-DryNeb will be tested with our collaborator Dr. Pavin Mutilli at the University of New Mexico (UNM). NHT facilities are located on the Lovelace Respiratory Research Institute (LRRI) campus in Albuquerque, NM. NHT will utilize this unique location and LRRI’s scientific expertise to perform proof of principle efficacy and safety studies in guinea pigs. **We have further recruited clinical and regulatory expertise, Drs. Betty Change and Don Burstyn, to ensure we have considered “next steps” as the project progresses toward the clinical and a Phase II SBIR submission.** At project’s end NH101 will be ready to proceed to IND-enabling toxicology studies funded through a Phase II SBIR or alternate sources.


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: 2022 ( Subtotal = $0 )
2022	2020	NOB HILL THERAPEUTICS INC	5901 INDIAN SCHOOL RD NE	ALBUQUERQUE	NM	87110	BERNALILLO	USA	Cardiovascular Diseases Research	000	1	1/31/2022	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $299,058 )
2020	2020	NOB HILL THERAPEUTICS, INC.	5901 INDIAN SCHOOL RD NE UNIT 209	ALBUQUERQUE	NM	87110	BERNALILLO	USA	Cardiovascular Diseases Research	000	1	2/6/2020	NEW	$299,058
														Subtotal = $299,058

Grand Total All Awards = $299,058

Top

All Categories

About

Search

Reports

Data Submission

Award Information

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: R43HL147749

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: 07/31/2021

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer