# Preclinical Development of a ME-1001, a Synthetic Lung Surfactant

> **NIH NIH R44** · MOLECULAR EXPRESS, INC. · 2024 · $999,853

## Abstract

Project Summary/Abstract
Surfactant deficiency in preterm infants causes the neonatal respiratory distress syndrome (NRDS). NRDS
directly causes mortality and morbidity. NRDS also increases the risk of intraventricular hemorrhage,
bronchopulmonary dysplasia, and nosocomial infections. The burden of NRDS has been conservatively
estimated at 1% of all live births, or 1.4 million neonates globally, with a reported case fatality for untreated NRDS
of 57 to 89% in low- and middle-income countries. Although animal-derived surfactants for treating NRDS
developed in the 1980s greatly decreased preterm infant morbidity and mortality, fewer than one-third of
premature infants receive surfactant treatment (based on surfactant sales). Cost constraints and lack of supply
are primary factors for why the remaining two-thirds are not treated. To help fill this need, Molecular Express,
Inc. is completing the late-stage development and preclinical activities for ME-1001, an investigational lung
surfactant comprised of the Super Mini-B peptide, which mimics Surfactant Protein B, the protein component
primarily responsible for lung surfactant activity, as well as the three major lipids of natural human lung surfactant.
ME-1001 is a fully synthetic lung surfactant - i.e., it is not limited by supply as is the case with animal derived
products and has significant advantages in being well-defined with consistent activity, product uniformity, and
economy of manufacturing over currently marketed animal and synthetic lung surfactants. In this SBIR Phase II
application, the Company will perform the pre-clinical activities that are needed to advance ME-1001 into the
clinic. Successful execution of the proposed activities will advance the development of a synthetic lung surfactant
with commercial attractiveness due to advantages over other synthetic and native surfactants in activity and
manufacturing economy. Reduced cost to consumers can potentially translate into broadened surfactant
treatment of NRDS and potentially other indications for use thus exerting a significant impact on improving global
public health.

## Key facts

- **NIH application ID:** 10922513
- **Project number:** 1R44HL172526-01A1
- **Recipient organization:** MOLECULAR EXPRESS, INC.
- **Principal Investigator:** Gary Fujii
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $999,853
- **Award type:** 1
- **Project period:** 2024-05-15 → 2026-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10922513

## Citation

> US National Institutes of Health, RePORTER application 10922513, Preclinical Development of a ME-1001, a Synthetic Lung Surfactant (1R44HL172526-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10922513. Licensed CC0.

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