10/03/2022, 5876 characters
MARIETTA, Ga. , May 22 /PRNewswire/ — Further expansion plans in Europe include up to ten clinical trial sites in Spain by the end of Q32022 and up to three centers in Italy by the end of 2022
Zelpultide alfa has been approved as a generic name for our AT-100 (rhSP-D) by the two authoritative organizations, the United States Adopted Names (USAN) Council and the INN program of the World Health Organization (WHO).
Airway Therapeutics Inc. (Airway), a biopharmaceutical company developing a new class of biologics to break the cycle of injury and inflammation in patients with respiratory and inflammatory diseases, announced that in the ongoing Phase 1b study for Zelpultide alfa (rhSP-D ) for preventive use in very premature babies at risk of bronchopulmonary dysplasia (BPD) was the first patient treated in Spain. Airway is already active at 10 locations in the US. Expansion into Europe allows for broader investigation and accessibility of zelpultide alfa as a potential anti-inflammatory and anti-infective preventive therapy for the severe respiratory disease BPD. In addition to BPD, zelpultide alfa is being evaluated in an ongoing Phase 1b clinical trial for COVID in the United States.
Every year, 2.5 million very premature babies worldwide are at risk of developing BPD. Babies with BPD are at increased risk of death and of chronic complications throughout life, including recurrent pneumonia, asthma, and neurodevelopmental disorders. BPD is a serious respiratory disease that is common in very premature babies whose lungs are not fully developed and who require mechanical ventilation. Up to 80 percent of babies born before 27 weeks’ gestation require respiratory support to survive. Although these procedures are life-sustaining, they can damage delicate lung tissue, cause inflammation and infection, and lead to scarring and susceptibility to infection and disease, including BPD.
“Despite the global prevalence of BPD, treatment options for this disease remain very limited. At Airway, we are committed to reducing the incidence, severity and long-term consequences of BPD in as many patients as possible,” says Dr. Marc Salzberg, CEO. “In Spain, we have approval to expand the Phase 1b study for zelpultide alfa . in patients outside the United States. This is an essential step in understanding the potential of zelpultide alfa in very premature infants, with the aim of making our new therapy accessible worldwide.”
“Preclinical studies of Zelpultide alfa show that this potential therapy holds more promise than the current standard of care. I am proud to work with Airway to investigate the potential of Zelpultide alfa in eligible very premature infants in Spain, with the aim of improving short- and long-term outcomes for these fragile infants,” explains Dr. Máximo Vento, Head of the Department of Neonatology and Head of Clinical Studies at La Fe Spanish University and Polytechnic in Valencia, Spain.
Information about zelpultide alfa
Zelpultide alfa (rhSP-D) is a new recombinant version of the endogenous human protein hSP-D, a protein that reduces inflammation and infection in the body while modulating the immune response to break the cycle of injury and inflammation. Airway is focused on the development of Zelpultide alfa for the prevention of BPS in extremely premature infants and as a therapeutic agent for critically ill Covid-19 patients. The anti-inflammatory and anti-infective properties of zelpultide alfa also make it a potential treatment for other respiratory diseases such as influenza, respiratory syncytial virus (RSV) and inflammatory diseases outside the lungs. The FDA and the European Medicines Agency have granted Zelpultide alfa orphan drug designation status.
About Airway Therapeutics
Airway Therapeutics, Inc., based in Cincinnati, Ohio, 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. It starts with the most vulnerable patient groups. The current randomized, blinded phase 1b study of zelpultide alfa is currently enrolling very premature infants requiring mechanical ventilation. The clinical study will validate the feasibility of intratracheal administration of zelpultide alfa in a randomized dose escalation study to evaluate safety and tolerability in 36 patients. Airway expects preliminary data from the Phase 1b study in Q1 2023. For more information about the study, see the following clinicaltrials.gov identifier: NCT04662151.
Zelpultide alfa is Airway’s first development candidate for the prevention of BPD in very premature infants. At the same time, Airway is conducting a phase 1b study to treat critically ill COVID-19 patients who require mechanical ventilation. Visit https://www.airwaytherapeutics.com for more information.
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