Airway Therapeutics, Inc. has received a USD 1.9 million NHLBI R44 SBIR grant to fund a Phase IIb/III trial of zelpultide alfa, a recombinant human Surfactant Protein-D (rhSP-D), for prevention of bronchopulmonary dysplasia (BPD) in extremely preterm neonates — a condition affecting roughly 46,000 infants annually in the US and Europe with no FDA-approved preventive therapy. The grant follows a USD 50 million public offering held earlier this month.
Zelpultide alfa mimics the endogenous immune-regulatory protein SP-D, which modulates pulmonary inflammation, supports pathogen clearance, and attenuates oxidative stress in the developing lung. The rationale for targeting SP-D is that preterm infants are deficient in this protein, and its absence is thought to contribute to the aberrant inflammatory cascade underlying BPD. Phase Ib data cited in the grant reported approximately 50% reduction in BPD incidence in treated infants versus controls, alongside reductions in mechanical ventilation duration and steroid use, though those results come from a small, early-stage study.
The adaptive seamless Phase IIb/III design will enroll 150 neonates born at 22 to 27 weeks gestational age across approximately 90 international sites, with the NIH award covering enrollment at 28 US sites. Two dose levels — 4 mg/kg and 6 mg/kg — will be evaluated against placebo and standard of care. The primary endpoint is the composite of grade 2 or grade 3 BPD or death at 36 weeks postmenstrual age, with a 24-month follow-up to capture neurodevelopmental outcomes. Principal investigators are Judy L. Aschner and Marc Salzberg.
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