Clinical Trials Information

Phase 2b/3

2-part seamless trial to evaluate the safety, tolerability, and efficacy of zelpultide alfa in BPD

Status: Set to begin in late Q4 2025.

The Part-1 Phase 2b trial will evaluate two different dose levels of zelpultide alfa administered for up to seven days, compared to placebo. Following completion of treatment in 150 patients (50 per arm), the optimal dose level will be selected based on risk-benefit for continuation into Phase 3, during which approximately 216 additional patients will be enrolled to confirm efficacy. As part of the study, Airway Therapeutics will assess a three-day consecutive BPD evaluation endpoint, which may contribute to the development of improved outcome measures during the studies.

Baby with brown hair and blue eyes

Phase 1B

Trial to evaluate the safety, tolerability, and efficacy of zelpultide alfa in BPD

Status: Finalized.

The trial was designed as a randomized, blinded, placebo controlled study, and enrolled four cohorts based on gestational age (3 dose escalation cohorts for up to 2 days in 25 to <29 weeks GA babies and one larger cohort including 23 and 24 week GA babies for up to 7 days, 23 to <29 weeks) across 10 U.S. and 10 Spanish study sites. Key inclusion criteria require patients to be intubated, on mechanical ventilation, and have received at least one dose of Curosurf® after birth. Additionally, patients were required to receive the first dose of zelpultide alfa or air-sham within 48 hours of intubation.

Phase 1B

trial to evaluate the safety, tolerability, and feasibility of intervention with zelpultide alfa in adult intubated patients receiving invasive mechanical ventilation with severe COVID-19 infection or respiratory failure secondary to severe community acquired pneumonia

Status: Finalized.

The study was designed as a single-arm, open-label study. The trial enrolled two cohorts based on dose escalation, 75mg (n=3) and 150 mg (n=2) per day of zelpultide alfa up to seven days while intubated and mechanically ventilated in one center in the U.S. Key inclusion criteria required adult patients with severe SARS-CoV-2 infection or severe CAP with respiratory failure, intubated and receiving mechanical ventilation. The trial results indicated that treatment with zelpultide alfa was safe, feasible and tolerable. Additional studies in the CAP/ARDS or other adult respiratory indications are necessary to assess efficacy.