Zelpultide Alfa to Prevent BPD in High-Risk Preterm Babies
Official title: A Randomized,Phase 2b/3 Study to Evaluate the Efficacy and Safety of Zelpultide Alfa in Preventing BPD in High-Risk Preterm Neonates Compared to Standard of Care.
Funded at Airway Therapeutics, INC. · NIH-11407847 · Data updated 2026-11-12
A clinical trial tests a new therapy called zelpultide alfa to help prevent bronchopulmonary dysplasia in very preterm babies at high risk.
Quick facts
| Grant type | Sbir 2 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Airway Therapeutics, INC. NIH-funded |
| Lab location | 1 site (Atlanta, UNITED STATES) |
| Project start | September 10, 2026 |
| Project end | June 30, 2027 |
| Funding year | 2026 |
| Award (this year) | $1,906,253 |
| NIH project number | 1R44HL186892-01 |
| Project ID | NIH-11407847 on NIH RePORTER |
Who could benefit from this research
✓Could help
Very preterm neonates (gestational age 22 0/7 to 27 6/7 weeks) at high risk for BPD, enrolled within the study timeframe.
✕Less likely to help
Preterm infants outside the specified gestational age range or not at high risk for BPD may not benefit from this intervention.
What this research studies
This study is a Phase 2b/3 trial that will test if zelpultide alfa, a recombinant human SP-D, can reduce breathing-related complications in preterm neonates at high risk for BPD. It compares two dosing levels to standard care and placebo in a multicenter, randomized, double-blind design with adaptive elements. If successful, the treatment could offer a new way to address the underlying inflammation and oxidative stress linked to BPD. Participants will be very preterm infants enrolled across about 90 international sites, with safety and efficacy monitored closely. The goal is to provide evidence for a preventive option that could improve long-term respiratory outcomes for these vulnerable babies.
Why it matters
Potential benefit: If the trial is successful, zelpultide alfa could reduce the incidence of BPD and improve respiratory health for high-risk preterm infants.
How similar studies have gone: Preclinical data and early-phase results have shown safety signals and potential efficacy for this approach, supporting progression to Phase 2b/3.
Where this research is happening
-
Airway Therapeutics, INC.
Atlanta, United States Active
Researchers
- Principal investigator: Salzberg, Marc — Airway Therapeutics, INC.
- Study coordinator: Salzberg, Marc
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.