Windtree Therapeutics Inc (WINT)

[H2R]

Successful Completion of Enrollment in AEROSURF® Phase 2b

http://windtreetx.investorroom.com/2017-06-01-Windtree-Announces-Successful-Completion-of-Enrollment-in-AEROSURF-R-Phase-2b-Clinical-Trial-for-the-Treatment-of-Respiratory-Distress-Syndrome-RDS-in-Premature-Infants

WARRINGTON, Pa., June 1, 2017 /PRNewswire/ -- Windtree Therapeutics, Inc. (OTCQB: WINT), a biotechnology company focused on developing aerosolized KL4 surfactant therapies for respiratory diseases, today announced completion of enrollment in its AEROSURF® phase 2b clinical trial evaluating aerosolized KL4 surfactant for the treatment of respiratory distress syndrome (RDS) in premature infants, 28 to 32-week gestational age, receiving nasal continuous positive airway pressure (nCPAP) for RDS. A total of 221 patients have been enrolled at 52 sites in North America, Europe and Latin America and the Company reaffirms its plan to announce top-line results for the trial in July 2017.

Windtree Therapeutics, Inc. - Striving to deliver hope for a lifetime
"Completing enrollment in this phase 2b trial represents a significant milestone in our AEROSURF clinical development program and brings us another step closer to potentially realizing our goal of transforming the management of RDS in premature infants," commented Steve Simonson, M.D., Senior Vice President and Chief Medical Officer. "We would like to especially thank the families of premature infants who participated in the trial. We are grateful for the broad-based support of the neonatology community and, in particular, thank the clinicians and their caregiver teams that are participating in this important endeavor. We look forward to data analysis and sharing top-line results in July."

AEROSURF is a novel, investigational drug/device combination product that combines the Company's proprietary KL4 surfactant and aerosolization technologies. AEROSURF is being developed to potentially reduce the need for invasive endotracheal intubation and mechanical ventilation in the treatment of premature infants with respiratory distress syndrome (RDS). In September 2016, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for AEROSURF for the treatment of premature infants with RDS.

AEROSURF Phase 2b Trial Design
The AEROSURF phase 2b clinical trial is a multicenter, randomized, controlled study with masked treatment assignment in up to 240 premature infants receiving 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 assessing: (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