AEROSURF Phase 2b Clinical Trial on Premature Infants with Respiratory Distress Syndrome

AEROSURF Phase 2b Clinical Trial on Premature Infants with Respiratory Distress Syndrome

Discovery Laboratories recently announced the beginning of its Phase 2b clinical trial for AEROSURF in premature babies of gestational age 26 to 32 weeks who receive noninvasive continuous positive aerosol nasal airway pressure (nCPAP) as a therapy for respiratory distress syndrome, commonly called RDS.

The trial aims to evaluate premature babies who receive aerosolized KL4 surfectant, including repeat doses if needed, compared to simply nCPAP alone without the surfectant.

Discovery Laboratories is a biotech company focused on developing aerosolized KL4 surfactant therapies for respiratory diseases.

According to the company, with AEROSURF, neonatologists may administer aerosolized KL4 surfactant to newborns and infants supported by nCPAP, with no need to subject them to invasive endotracheal intubation and mechanical ventilation – which is now needed to administer surfactant therapy to premature infants.

“Currently, surfactant therapy is primarily administered to premature infants with RDS via invasive endotracheal intubation. The trend in neonatology is to use less or noninvasive methods to treat RDS, but these preclude the administration of surfactant therapy in a timely manner. AEROSURF allows for noninvasive delivery of aerosolized KL4 surfactant to premature infants receiving nCPAP,” Dr. Steve Simonson, Discovery Labs’ chief development officer, stated in a press release.

The company is testing AEROSURF to determine if it can potentially reduce or eliminate the need for endotracheal intubation and mechanical ventilation when treating premature children with RDS.

The AEROSURF Phase 2b clinical trial is a randomized, multicenter, controlled study with masked treatment assignment. The trial will include 250 premature children in 50 North American states, and in Canada, Europe and Latin America.

Aerosolized KL4 surfactant will be evaluated in two dose groups — 25 and 50 minutes, including infants’ capability for repeat doses — compared to premature babies receiving standard care of nCPAP. The goal of the trial is to show evidence of efficacy, and if successful, help in the design of a Phase 3 trial of AEROSURF.

“The initiation of the Phase 2b trial is an important next step to build upon the results observed in our recently completed Phase 2a clinical trials in premature infants 29 to 34 weeks gestational age.” Dr. Simonson said. “Data from these trials are encouraging and suggest that AEROSURF may reduce the incidence of nCPAP failure and the need for intubation and delayed surfactant therapy. If this result is confirmed as we advance our development program, AEROSURF could represent a significant medical advancement in neonatology.”

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