Efficacy of Zelpultide Alfa in Preterm Neonates at High Risk of Developing Bronchopulmonary Dysplasia (BPD)

Launched by AIRWAY THERAPEUTICS, INC. · Mar 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called Zelpultide Alfa to see if it can help prevent a serious lung condition called Bronchopulmonary Dysplasia (BPD) in very premature babies. BPD can occur in infants who are born extremely early, and this trial aims to find out if adding Zelpultide Alfa to the usual care can reduce both the chances of developing severe BPD and the risk of death.

To participate in this trial, babies must be born between 23 and 27 weeks of pregnancy and need to be on a breathing machine called mechanical ventilation. They should also have received a specific treatment for their lungs shortly after birth. Parents or guardians will need to give consent for their child to join the study. If eligible, babies will receive Zelpultide Alfa or a placebo (a substance with no active ingredients) through a breathing tube, with treatments given every 24 hours for up to a week. This study is currently seeking participants, and it’s a chance to contribute to important research that could improve care for future premature infants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Born between gestational age (GA) 23 0/7 to 27 6/7 weeks, inclusive.
• • 2. Received at least 1 dose of SOC-indicated animal-derived pulmonary surfactant treatment after birth.
• • 3. Intubated and on invasive mechanical ventilation per SOC.
• • 4. Able to receive the first dose of zelpultide alfa or air-sham at least 15 min after the surfactant administration but within 96 h of birth and within 48 h from the start of invasive mechanical ventilation. Subjects extubated and re-intubated after their pulmonary surfactant dose(s) are eligible as long as the inclusion criteria are met.
• • 5. Informed consent and personal information authorization form signed by the subject's parent(s) or legal guardian(s).
• Exclusion Criteria:
• • 1. Birth weight \< 400 g or \> 1,500 g.
• 2. Major apparent congenital abnormalities impacting cardio and pulmonary function identified before randomization, such as, but not limited to:
• • Clinically relevant Potter-like syndrome and any pulmonary congenital anomalies,
• • Clinically relevant congenital diaphragmatic hernia,
• • Omphalocele or gastroschisis, esophageal atresia,
• • Known or suspected cyanotic congenital heart disease (ie, tetralogy of fallot, transposition of the great arteries, etc).
• • 3. Active do no resuscitate (DNR) order in place.
• • 4. History of allergy or sensitivity to any surfactant or any component of zelpultide alfa.
• • 5. Concurrent enrollment in any clinical study that utilizes treatments (investigational medical products or devices) outside of SOC or participation in studies within the last 30 days (or 5 half-lives of an IMP) prior to birth (for the mother) or up to week 36 PMA.
• • 6. Any condition or situation that, in the Investigator's judgement, puts the neonate at significant risk, could confound the study results, or may interfere significantly with the neonate's participation in the study.