# Development of a dry powder inhalation product against Respiratory Syncytial Virus based on an endogenous anionic pulmonary surfactant lipid

> **NIH NIH R44** · CELESTIAL THERAPEUTICS INC. · 2023 · $290,117

## Abstract

PROJECT SUMMARY
Human respiratory syncytial virus (hRSV) infection has an estimated global incidence of 33 million cases in
children younger than 5 years, with up to 234,000 dying of the disease. Although often characterized as a
pediatric disease, RSV infection in adults aged 65 years or older represent a substantial health burden. Recent
failures of late-phase trials for vaccines and therapies based on monoclonal antibodies (mAb) prompt the
development of novel interventions for RSV. To fill this urgent clinical need, Celestial Therapeutics is developing
an endogenous anionic pulmonary surfactant lipid, palmitoyl-oleoyl-phosphatidylglycerol, to be administered via
dry powder inhalation that acts as a dual-modal antiviral and anti-inflammatory agent. The mode of action of
palmitoyl-oleoyl-phosphatidylglycerol has been extensively studied, however, to develop it into a stable and
effective drug product, a dry powder formulation needs to be developed. Celestial therapeutics has already
gathered preliminary data regarding the generation of a dry powder with the desired particle size. In this SBIR
Fast-Track project, Celestial Therapeutics will complete the development of the dry powder inhalation (DPI)
formulation suitable for inhalation. The Phase I study will 1) demonstrate the efficacy of DPI in vivo as a treatment
and/or prophylactic agent against RSV when administered via inhalation; 2) confirm the safety profile of the DPI,
and 3) show that the DPI has the desired pharmacokinetic profile in vivo. The successful outcomes of Phase I
will open to a Phase II project where Celestial Therapeutics will optimize manufacturing and define quality
controls (Aim II-1), followed by pivotal preclinical safety pharmacology and toxicology studies (Aim II-2). The DPI
will improve the current clinical practice as it will be the first available dual-modal antiviral/anti-inflammatory
prophylactic and interventional treatment against RSV. Serving both as treatment and prophylaxis, the DPI will
be preferred over mAb injections. Upon completion of the Phase II project, a pre-IND meeting will be held with
the FDA to discuss the data gathered.

## Key facts

- **NIH application ID:** 10697027
- **Project number:** 1R44AI177056-01
- **Recipient organization:** CELESTIAL THERAPEUTICS INC.
- **Principal Investigator:** Ajay Gupta
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $290,117
- **Award type:** 1
- **Project period:** 2023-04-11 → 2025-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10697027

## Citation

> US National Institutes of Health, RePORTER application 10697027, Development of a dry powder inhalation product against Respiratory Syncytial Virus based on an endogenous anionic pulmonary surfactant lipid (1R44AI177056-01). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10697027. Licensed CC0.

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