Airway Therapeutics has completed the dose escalation part of its Phase Ib trial of zelpultide alfa (AT-100) for preventive use in very preterm infants at bronchopulmonary dysplasia (BPD) risk.
Designed to establish the safety and tolerability of zelpultide alfa, the randomised, blinded, air-sham controlled trial is being conducted in the US and Spain.
The company started enrolling patients from the previous month for daily treatment up to seven days using the highest dose of zelpultide alfa (rhSP-D).
This dose was administered to the patients, after a Data Safety Monitoring Committee (DSMC) reported no safety concerns.
Airway’s subsidiary Airway Spain will lead the Phase Ib trial and subsequent clinical trials across the EU.
Airway CEO and chief medical officer Marc Salzberg said: “This is a significant milestone in our efforts to protect these infants from suffering severe BPD.
“The very favourable safety profile is particularly important in these extremely vulnerable preterm neonates. The DSMC confirmed the excellent safety profile of zelpultide alfa following completion of the third cohort of infants who received the highest dose.
“This dose is being used in a fourth and final cohort which now also includes infants born at 23 – 24 weeks, the earliest gestational age in our study.”
The company plans to announce interim analysis data in the second quarter of this year.
Apart from treating BPD, Zelpultide alfa is used for treating Covid/CAP in seriously ill mechanically ventilated patients.