- Favorable safety profile confirmed also in fourth and final cohort including babies born at earliest gestational age of 23 to 24 weeks
- Interim analysis is complete and full results are expected by October 2023
- Company expects to begin a Phase 3 trial by end of 2023
05/06/2023 — ATLANTA — (BUSINESS WIRE)
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 completed enrollment in its Phase 1b trial of zelpultide alfa for preventive use in very preterm infants at risk for bronchopulmonary dysplasia (BPD).
The last of 12 patients recruited into the fourth and final cohort of the study has been treated. These infants, born at 23 to <29 weeks, received daily treatment up to 7 days at the highest dose of zelpultide alfa (rhSP-D). The fourth cohort began recruitment March 28, 2023, following a Data Safety Monitoring Committee (DSMC) report finding no safety concerns at the conclusion of the trial’s dose escalation portion, and included the extremely preterm neonates born as early as weeks 23 and 24.
“We are very pleased to report that the recruitment of the first clinical study with zelpultide alfa has been successfully completed according to protocol,” said Airway CEO and Chief Medical Officer Marc Salzberg, M.D. “This is another major step in the development of this novel drug for the prevention of BPD in very preterm born babies.”
An interim analysis of the Phase 1b has been completed, and full trial results are expected by October 2023. The company plans to begin a Phase 3 trial by the end of 2023 which will involve at least 80 hospitals in North America and across Europe.
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. A total of 37 infants were enrolled at 20 hospitals in the U.S. and Spain. The 25 infants in the dose escalation portion were born at 25 weeks to <29 weeks gestational age. 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.