Windtree Therapeutics' AEROSURF (Lucinactant For Inhalation) Phase 2a Data Presented At The 2016 International Congress Of Union Of European Neonatal And Perinatal Societies
Published: Nov 29, 2016
WARRINGTON, Pa., Nov. 28, 2016 /PRNewswire/ -- Windtree Therapeutics, Inc. (Nasdaq: WINT), a biotechnology company focused on developing aerosolized KL4 surfactant therapies for respiratory diseases, today announced the Company's previously released AEROSURF® (lucinactant for inhalation) phase 2a data was presented at the 6th International Congress of European Neonatal and Perinatal Societies (UENPS) held in Valencia, Spain by Jan Mazela, M.D., PhD, Poznan University of Medical Sciences. The data demonstrate that AEROSURF administered non-invasively via nasal continuous positive airway pressure (nCPAP) in premature infants 29-34 weeks gestational age (GA) with respiratory distress syndrome (RDS) was generally safe and well tolerated and may be reducing the incidence of nCPAP failure (the need for invasive intubation and delayed surfactant therapy). Additionally, the abstract received the UENPS Congress 2016 Best Abstract Award.
"We are very pleased with the safety and tolerability seen with AEROSURF in the phase 2 program thus far and are encouraged by the reduction of nCPAP failures seen when using AEROSURF in preterm neonates 29-34 weeks GA," stated Steve Simonson, M.D, Senior Vice President and Chief Development Officer. "Though further study is required, if we are successful, we believe AEROSURF will represent a transformational change in the management of RDS. We are very pleased that UENPS acknowledged this work with the Best Abstract Award at its Congress. We believe this award recognizes the importance to the neonatal community of pursuing a non-invasive treatment for RDS and acknowledges the quality of the study and the potential of AEROSURF."
About AEROSURF® (lucinactant for inhalation) and KL4 Surfactant Pipeline
Windtree's lead product candidate is AEROSURF® (lucinactant for inhalation), a novel, investigational combination 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). Enrollment is ongoing in a phase 2b clinical trial to study AEROSURF administered to premature infants 29 to 32 week GA receiving nasal continuous positive airway pressure (nCPAP) for RDS, compared to infants receiving nCPAP alone. The phase 2b trial is a blinded, global trial with clinical sites in North America, Europe and Latin America and will study up to 240 infants. Additionally, the company is currently conducting a separate phase 2a trial in 26-28 week GA infants.
In addition to the study of RDS, Windtree continues to conduct, with support from the National Institutes of Health, pre-clinical investigation of aerosolized KL4 surfactant in various acute lung injury conditions including radiation induced lung injury and viral induced lung injury.
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's 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 include those risks related to Windtree's aerosolized KL4 surfactant development programs, including for AEROSURF, which may involve time-consuming and expensive clinical trials that may be subject to potentially significant delays or regulatory holds, or fail; risks related to the development of aerosol delivery systems (ADS) and related components; risks related to the manufacture by contract manufacturers or suppliers of drug products, drug substances, ADS and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including those of the U.S. Food and Drug Administration or other regulatory authorities that may require significant additional activities, or may not accept or may withhold or delay consideration of applications, or may not approve or may limit approval of Windtree's products; and other risks and uncertainties described in Windtree's filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto.
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SOURCE Windtree Therapeutics, Inc.