FDA accepts Airway’s IND for AT-100 for bronchopulmonary dysplasia treatment in preterm infants
Bronchopulmonary dysplasia treatment : Airway Therapeutics said that the US Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application for developing AT-100 (rhSP-D) as a preventive treatment for bronchopulmonary dysplasia (BPD) in preterm infants.
The US biopharma company will begin a phase 1b randomized clinical trial for confirming the feasibility of administrating AT-100 intratracheally and its beneficial safety and tolerability profile. Initial results of the early-stage clinical trial of the potential bronchopulmonary dysplasia treatment are expected in late 2021.
After the phase 1b trial, Airway Therapeutics will carry out a randomized pivotal trial with preliminary results estimated to be released as early as the second half of 2023.
Marc Salzberg – CEO of Airway Therapeutics, commenting on the bronchopulmonary dysplasia treatment candidate AT-100, said: “Preterm infants with BPD have higher mortality, and those who survive suffer from lifelong chronic consequences. With no approved treatments for BPD, AT-100 has potential to reduce incidence and severity of BPD, related short- and long-term consequences, and ultimately improve the survival of these vulnerable patients.
“We are excited to advance this new therapy into the clinic with the potential to deliver novel therapies for patients in desperate need of new treatment options.”
FDA accepts Airway Therapeutics’ IND for bronchopulmonary dysplasia treatment candidate AT-100 in preterm infants. Photo courtesy of The U.S. Food and Drug Administration/Wikipedia.org.
AT-100 is a human recombinant protein and an engineered form of an endogenous protein. In preclinical studies, the bronchopulmonary dysplasia treatment candidate showed that it could decrease inflammation and infection caused in very preterm babies, by mechanical ventilation and oxygen support, and eventually reducing the onset of lung damage.
Airway Therapeutics has also filed an additional IND application with the FDA for AT-100 as a possible treatment of Covid-19. Apart from its anti-inflammatory characteristics, AT-100 in preclinical studies had demonstrated potential to block replication of the SARS-CoV-2 virus and promote viral elimination.
The US biopharma company believes that AT-100 can also reduce secondary infections in Covid-19 patients, who are on mechanical ventilation.