Discovery Labs Announces Results of Phase 2a Clinical Trial of AEROSURF®
Source: PR Newswire (US)
WARRINGTON, Pa., May 14, 2015 /PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company focused on developing aerosolized KL4 surfactant therapies for respiratory diseases, today reported top line data from its recently completed AEROSURF® phase 2a clinical trial in premature infants with respiratory distress syndrome (RDS). Key objectives of the study were achieved, including (1) the primary objective of demonstrating the safety and tolerability of a single exposure of aerosolized KL4 surfactant administered in three escalating inhaled doses to premature infants 29 to 34 week gestational age and receiving nasal continuous positive airway pressure (nCPAP) for RDS, compared to infants receiving nCPAP alone, and (2) establishing proof of concept for the Company's proprietary technology platform based on physiological data suggesting that aerosolized KL4 surfactant is being delivered into the lung of premature infants, and acceptable performance of the novel capillary aerosol generator (CAG) technology in the neonatal intensive care unit (NICU).
"The ability to administer surfactant without invasive endotracheal intubation in the management of premature infants with RDS would represent a significant medical advancement. We are encouraged by the results from this AEROSURF phase 2a clinical trial as it represents a positive indication that our technology has the potential to achieve this goal. While the trial was designed as a safety study and the number of patients was limited, the results suggest that the Company's combination drug/device product has the ability to deliver aerosolized KL4 surfactant to the lungs of premature infants with RDS," commented Steve Simonson, M.D., Discovery Labs' Chief Development Officer. "These results will inform and improve the further development of our AEROSURF clinical program."
AEROSURF is Discovery Labs' combination drug/device product that combines the Company's novel synthetic peptide-containing (KL4) surfactant and its proprietary aerosol delivery technologies, including the CAG, that are designed to enable efficient delivery of aerosolized KL4 surfactant. Currently, the available surfactants (animal-derived) can only be administered using endotracheal intubation with mechanical ventilation, invasive procedures that may each result in serious complications and other respiratory conditions. With AEROSURF, neonatologists potentially will be able to administer aerosolized KL4 surfactant to premature infants supported with nCPAP alone, without having to resort to invasive intubation and mechanical ventilation.
The AEROSURF phase 2a trial was a multi-center, open-label trial to evaluate safety and tolerability of a single dose of aerosolized KL4 surfactant in premature infants 29 to 34 weeks gestational age who are receiving nCPAP for RDS ("AEROSURF group"; n = 24), compared to infants receiving nCPAP alone ("control group"; n=24). The study evaluated three escalating doses of AEROSURF.
Discovery Labs' management will host a conference call and live webcast, with a slide presentation including data from the clinical trial, today at 8:00 a.m. Eastern time to review and discuss the results of the trial. See below for details of the call.
