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
Ended Project Grant Awarded Last action
- Award ID
- R44HL147749
- Recipient
-
Nob Hill Therapeutics, Inc. UEI EL4UKHCBUCM3
- Awarding agency
-
National Heart Lung and Blood Institute
National Institutes of Health, Department of Health and Human Services
- Obligated
- $2,880,849
Award facts
- Assistance listing
- 93.837 Cardiovascular Diseases Research
- Completion date
- Place of performance
- New Mexico, USA
Award details come from USAspending.gov.
Description
- Abstract
- 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.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Amendment | $0 | |
| Amendment | $564,303 | |
| Amendment | $1,158,273 | |
| Original award | $1,158,273 |
Quick answers
Who received award R44HL147749?
R44HL147749 was awarded to Nob Hill Therapeutics, Inc. by National Heart Lung and Blood Institute (National Institutes of Health) on February 15, 2020.
How much is award R44HL147749 worth?
$2,880,849 has been obligated on R44HL147749.
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