ICYMI: Dose Escalation Study Phase Completed on Zelpultide Alfa for BPD

 

Ventilatory assistance, NG tubes, tracheostomy: all of these may be used to care for infants born with bronchopulmonary dysplasia (BPD), a chronic lung disease that most commonly affects preterm infants. Airway Therapeutics, Inc. is working to develop a new therapy called zelpultide alfa (formerly AT 100) that could provide additional benefit to infants with BPD. This therapy is being evaluated in a Phase 1b study. According to a news release from April 2023, the dose escalation portion of the trial is now complete; initial findings suggest that there are no associated safety issues or concerns. 

Airway Therapeutics describes zelpultide alfa as: 

a novel recombinant human protein rhSP-d – an engineered version of an endogenous protein – that reduces inflammation and infection while modulating the immune response to break the cycle of injury and inflammation.

Within the dose escalation portion of the study, infants received a range of zelpultide alfa dosages. Even at the highest dosage, the therapy was safe. Now, researchers will explore this dose in a final cohort of preterm infants who were born between 23-24 weeks. More data will be available later this year. 

What is Bronchopulmonary Dysplasia (BPD)? 

Preterm infants are usually born at least 10 weeks before their due dates and may weigh less than 2 pounds. Because they are born so early, these infants usually require oxygen therapy and struggle to breathe. But long-term oxygen therapy and mechanical ventilation can irritate and damage the lungs, preventing them from forming properly. They don’t have enough surfactant, which keeps the lungs open and aids with breathing. Outside of preterm infants, BPD may occur in infants with severe respiratory distress syndrome or full-term births who were put on a breathing machine. Symptoms and characteristics of BPD may include:

  • Shortness of breath and/or difficulty breathing
  • Rapid or difficult breathing
  • Apnea (pauses in breathing)
  • Grunting or flared nostrils 
  • Wheezing
  • Cyanosis (a bluish color to the skin)
  • Skin retractions between the ribs or collar bones 
  • Asthma (complication) 
  • Pneumonia (complication) 

Treatment usually includes those listed at the start of this article. Infants with BPD can recover, but it can take years.