- DSMC finds no safety concerns, allows use of highest dose for continued administration.
- Interim analysis of the trial expected in next month
- Company opens Spanish subsidiary to lead EU clinical trials
ATLANTA, GEORGIA (April 11, 2023) – Airway Therapeutics, Inc., a biopharmaceutical company developing a new class of biologics to break the cycle of injury and inflammation for patients with respiratory and inflammatory diseases, announced today it successfully finished the dose escalation portion of its Phase 1b trial of zelpultide alfa for preventive use in very preterm infants at risk for bronchopulmonary dysplasia (BPD). Airway began recruiting patients on March 28, 2023 for daily treatment up to 7 days at the highest dose of zelpultide alfa (rhSP-D) following a Data Safety Monitoring Committee (DSMC) report of no safety concerns.
The Phase 1b trial is being conducted in the U.S. and Spain. Airway has established a subsidiary, Airway Spain SL, to lead the Phase 1b trial and subsequent clinical trials across the E.U.
“This is a significant milestone in our efforts to protect these infants from suffering severe BPD. The very favorable safety profile is particularly important in these extremely vulnerable preterm neonates,” said Airway CEO and Chief Medical Officer Marc Salzberg, M.D.
“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.”
As many as 2.5 million very preterm infants globally are at risk of developing BPD from lung damage caused by mechanical ventilation and oxygen support. Babies who develop BPD can suffer lifelong complications such as asthma and pneumonia as well as growth and developmental problems.
Zelpultide alfa is a recombinant version of the endogenous human SP-D, a protein essential to the lung’s immune defense in reducing inflammation and infection while modulating immune responses. The biologic is administered intratracheally during mechanical ventilation.
The Phase 1b trial is a randomized, blinded, air-sham controlled study to establish the safety and tolerability of zelpultide alfa. Interim analysis of the data is expected in early Q2 2023. The FDA and European Medicines Agency have granted orphan drug status to zelpultide alfa.
About Airway Therapeutics
Airway Therapeutics is a biopharmaceutical company developing a new class of biologics to break the cycle of injury and inflammation for patients with respiratory and inflammatory diseases, beginning with the most vulnerable populations. The company is advancing zelpultide alfa, a novel recombinant human protein hSP-D that reduces inflammation and infection in the body while modulating the immune response. Zelpultide alfa is Airway’s first candidate in development for prevention of BPD in very preterm infants and for treatment of COVID/CAP in seriously ill mechanically ventilated patients.