WARRINGTON, Pa., Sept. 19, 2016 -- Windtree Therapeutics, Inc. (WINT), a biotechnology company focused on developing aerosolized KL4 surfactant therapies for respiratory diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for AEROSURF® (lucinactant for inhalation) for the treatment of premature infants with respiratory distress syndrome (RDS). AEROSURF is a novel, investigational combination drug/device product that is being developed to deliver aerosolized KL4 surfactant to premature infants with RDS, potentially reducing the need for invasive endotracheal intubation and mechanical ventilation to administer surfactant therapy.

 

"This Fast Track designation for AEROSURF underscores the significant need to reduce the use of invasive intubation and mechanical ventilation, which are required to administer surfactant therapy, but may result in serious complications and increase the risk for other respiratory conditions," commented Craig Fraser, President and Chief Executive Officer. 

"By enabling non-invasive delivery of our aerosolized KL4 surfactant, we believe that AEROSURF will address a serious unmet medical need and potentially provide transformative clinical and pharmacoeconomic benefits. We look forward to continuing our work with the FDA to advance AEROSURF through the clinical development and regulatory approval process, with the goal of bringing a transformative therapy to treat premature infants in an expedited time frame."

 

The Fast Track program was created by the FDA to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs. Drugs that receive this designation benefit from more frequent communications and meetings with FDA to review the drug's development plan including the design of the proposed clinical trials, use of biomarkers and the extent of data needed for approval. Drugs with Fast Track Designation may qualify for priority review to expedite the FDA review process, if relevant criteria are met.

 

AEROSURF is currently being studied in a phase 2b clinical trial in premature infants 26 to 32-week gestational age receiving nasal continuous positive airway pressure (nCPAP) for RDS. The phase 2b trial includes clinical sites in North America, Europe and South America.

 

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.

 

Forward-Looking Statements

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, which 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, 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.