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news.US-based biotechnology firm Discovery Laboratories has started enrolment in the next phase of its Phase IIa clinical trial of Aerosurf, an investigational drug/device product developed to treat premature infants with respiratory distress syndrome (RDS).
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The company said that this next Phase IIa dose expansion trial is a multicenter, randomized, open-label, controlled study, which is expected to be completed in the fourth quarter of this year.
It is designed to evaluate the safety and tolerability of aerosolized KL4 surfactant administered in higher and repeat doses in premature infants 29 to 34 weeks gestational age (GA) who are receiving nasal continuous positive airway pressure (nCPAP) for RDS, compared to infants receiving nCPAP alone.
According to the company, results of this expansion trial are expected to provide further insight and data to support the design of the planned Aerosurf phase IIb clinical program.
According to the company all major objectives were achieved, including the primary objective of showing a favorable safety and tolerability profile of Aerosurf, establishing proof of concept for the company’s proprietary technology platform based on physiological data.
The data shows that aerosolized KL4 surfactant is being delivered into the lung of premature infants, and acceptable performance of the new capillary aerosol generator (CAG) technology in the neonatal intensive care unit (NICU).
Discovery Labs chief development officer Steve Simonson said: "We believe that, with higher and/or repeat doses, Aerosurf may have the potential to reduce the need for invasive intubation due to nCPAP failure in this fragile patient population.
"Our objective for this phase is to gain additional knowledge that can be incorporated into the design of our phase IIb clinical trial."
The company is developing Aerosurf to potentially reduce or eliminate the need for intubation and mechanical ventilation in the treatment of premature infants with RDS.