# 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

> **NIH NIH R44** · NOB HILL THERAPEUTICS, INC. · 2022 · $1,158,273

## Abstract

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.

## Key facts

- **NIH application ID:** 10484014
- **Project number:** 2R44HL147749-02
- **Recipient organization:** NOB HILL THERAPEUTICS, INC.
- **Principal Investigator:** Matthew Reed
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,158,273
- **Award type:** 2
- **Project period:** 2020-02-15 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10484014

## Citation

> US National Institutes of Health, RePORTER application 10484014, 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 (2R44HL147749-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10484014. Licensed CC0.

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