Windtree Receives SBIR Grant in Continued Support of AEROSURF® Phase 2b Clinical Trial

WARRINGTON, Pa., May 22, 2017 /PRNewswire/ -- Windtree Therapeutics, Inc. (OTCQB: WINT), a biotechnology company focused on developing aerosolized KL4 surfactant therapies for respiratory diseases, today announced that it has been awarded $0.9 million under a previously announced Phase II Small Business Innovation Research Grant (SBIR) valued at up to $2.6 million from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) to support the AEROSURF^® phase 2b clinical trial in respiratory distress syndrome (RDS). Windtree was awarded an initial $1.0 million under this grant in August 2016, and over the next year may be awarded up to an additional $0.7 million through the completion of the phase 2b clinical trial and one-year patient follow-up.

"We appreciate the NIH's continued support of our AEROSURF phase 2b RDS clinical trial," commented Craig Fraser, Windtree's President and Chief Executive Officer. "We believe that, with this award, the NIH has recognized the importance of our research and the potential for AEROSURF to transform the treatment of premature infants with RDS by enabling the administration of KL4 surfactant without invasive intubation and mechanical ventilation. We are pleased with our execution of the AEROSURF phase 2b clinical trial and look forward to announcing top-line results from this study in July 2017."

AEROSURF is a novel, investigational drug/device combination product that combines Windtree'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).  The AEROSURF phase 2b clinical trial is a multicenter, randomized, controlled study with masked treatment assignment in up to 240 premature infants receiving nasal continuous positive airway pressure (nCPAP) for RDS, and is designed to evaluate aerosolized KL4 surfactant administered to premature infants 28 to 32 week gestational age in two dose groups (25 and 50 minutes), with up to two potential repeat doses, compared to infants receiving nCPAP alone. The key objectives of this trial are to:

• evaluate efficacy by: (i) incidence of nCPAP failure (defined as the need for intubation and delayed surfactant therapy), (ii) time to nCPAP failure, and (iii) physiological parameters indicating the effectiveness of lung function;
• define the dose regimen(s) for the planned phase 3 clinical program
• provide an estimation of the expected efficacy margin of AEROSURF treatment; and
• further characterize the AEROSURF safety profile and impact on common complications of prematurity

The trial is being conducted in approximately 50 clinical sites in North America, Europe and Latin America. 

Research under this SBIR grant is being conducted by Robert Segal, MD, Principle Investigator at Windtree and supported by the NHLBI of the NIH under award number R44HL107000.  The content of this press release is solely the responsibility of the Company and does not necessarily represent the official views of the NIH.

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, including projections of future cash balances and anticipated cash outflows, to differ materially from the statements made.  Examples of such risks and uncertainties are 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.

SOURCE Windtree Therapeutics, Inc.

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