Zelpultide alfa has received Orphan Drug Designation from the European Medicines Agency and the US FDA.
Airway Therapeutics has dosed the first subject in its Phase Ib clinical trial of zelpultide alfa (rhSP-D) in Spain for preventative usage in very preterm infants who are at bronchopulmonary dysplasia (BPD) risk.
The trial is already underway at ten sites in the US.
The company plans to further extend the trial in Europe to include up to ten sites in Spain by end of the third quarter, and up to three sites in Italy by the end of this year.
A new recombinant form of the endogenous human protein hSP-D, zelpultide alfa is being developed for BPD prevention, as well as for treating Covid-19 in seriously-ill individuals.
hSP-D lowers the body’s inflammation and infection, and regulates the immune response for breaking the injury and inflammation cycle.
Zelpultide alfa has received Orphan Drug Designation from the European Medicines Agency and the US Food and Drug Administration (FDA).
The anti-inflammatory and anti-infective properties of the product could make it a potential therapy to treat various respiratory ailments such as respiratory syncytial virus, inflammatory diseases outside the lung, and influenza.
“In Spain, we received approval for the expansion of the Phase Ib trial for zelpultide alfa to patients outside the United States.
“This is an integral step toward understanding the potential of zelpultide alfa in very preterm infants, with the goal of making our novel therapy accessible globally.”
Apart from BPD, zelpultide alfa is currently being assessed in a Phase Ib trial for Covid-19 in the US.
