WARRINGTON, Pa., April 28, 2016 /PRNewswire/ -- Windtree Therapeutics, Inc. (NASDAQ: WINT) today announced that data from the AEROSURF® Phase 2a clinical program in premature infants 29 to 34 weeks gestational age (GA) with respiratory distress syndrome (RDS) will be presented as a poster at the 2016 Pediatric Academic Societies (PAS) Meeting to be held April 30 – May 3, 2016 in Baltimore, MD.
The AEROSURF phase 2a clinical program in premature infants 29 to 34 week GA consisted of two multicenter, randomized, open-label, controlled studies in a total of 80 premature infants receiving nasal continuous positive airway pressure (nCPAP) for RDS. The studies were designed to evaluate the safety and tolerability of aerosolized KL4 surfactant administered in five dose groups (15, 30, 45, 60 and 90 minutes), compared to infants receiving nCPAP alone. Overall, the safety and tolerability profile of the AEROSURF-treated groups was generally comparable to the control group. In addition, data suggest that AEROSURF may be reducing the incidence of nCPAP failure (the need for intubation and delayed surfactant therapy).
The PAS Meeting brings together thousands of pediatricians and other health care providers united by a common mission: improve the health and well-being of children worldwide. This international gathering includes researchers, academics, as well as clinical care providers and community practitioners. Presentations cover issues of interest to generalists as well as topics critical to a wide array of specialty and subspecialty areas. The PAS Meeting is produced through a partnership of four pediatric organizations that are leaders in advancement of pediatric research and child advocacy - American Pediatric Society (APS), Society for Pediatric Research (SPR), Academic Pediatric Association (APA), and American Academy of Pediatrics (AAP).
Windtree's lead product candidate is AEROSURF, a novel, investigational drug/device product that combines the Company's proprietary KL4 surfactant and aerosolization technologies. AEROSURF is being developed to potentially reduce or eliminate the need for endotracheal intubation and mechanical ventilation in the treatment of premature infants with respiratory distress syndrome (RDS). A phase 2b clinical trial in up to 240 premature infants was initiated late last year to study AEROSURF in premature infants 26 to 32-week gestational age receiving nasal continuous positive airway pressure (nCPAP) for RDS, compared to infants receiving nCPAP alone. The phase 2b trial is a global trial with clinical sites in North America, Europe and Latin America. The Company remains on track to complete enrollment in this trial by the end of 2016 and release top-line results in the first quarter of 2017.
About Windtree Therapeutics
Windtree Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel surfactant therapies for respiratory diseases and other potential applications. Windtree proprietary technology platform includes a synthetic, peptide-containing surfactant (KL4 surfactant) that is structurally similar to endogenous pulmonary surfactant — and novel drug-delivery technologies being developed to enable noninvasive administration of aerosolized KL4 surfactant. Windtree is focused initially on improving the management of respiratory distress syndrome (RDS) in premature infants and believes that its proprietary technology may make it possible, over time, to develop a pipeline of KL4 surfactant product candidates to address a variety of respiratory diseases for which there are few or no approved therapies.
For more information, please visit the Company's website at www.windtreetx.com.
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Examples of such risks and uncertainties, including those affecting Windtree Therapeutics' ability successfully to secure required additional capital when needed, complete its development programs, secure regulatory approvals for its product candidates in the U.S. and abroad, and realize the potential value and benefits of its RDS product portfolio, are described in its filings with the Securities and Exchange Commission, including its most recent reports on Forms 10-K, and any amendments thereto. Any forward-looking statement in this release speaks only as of the date on which it is made. Windtree Therapeutics assumes no obligation to update or revise any forward-looking statements.
SOURCE Windtree Therapeutics, Inc.