Windtree Announces Initial European Trial Sites Activated in AEROSURF® Bridging Study and a Collaboration for a Concomitant Independent Cerebral Physiology Study

WARRINGTON, Pa., June 24, 2020 /PRNewswire/ -- Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology and medical device company focused on developing drug product candidates and medical device technologies to address acute cardiovascular and pulmonary diseases, today announced that all initial European trial sites are active and enrolling or able to enroll patients into its AEROSURF® Phase 2b bridging study in premature infants with respiratory distress syndrome (RDS). In addition, the Company is announcing that select patients in this study may be co-enrolled in an investigator-sponsored study, being run in parallel to the bridging study. The concomitant study will evaluate changes in cerebral electroencephalography (EEG) and cerebral oxygenation during surfactant administration.

"Completing the activation of all initially planned European trial sites for the AEROSURF Phase 2b bridging study is a key milestone to substantiating this approach as a major potential paradigm shift in the treatment of RDS in premature infants," said Craig Fraser, chief executive officer of Windtree. "Now that all of these sites are open, we can look towards expanding to new sites in the EU and U.S. as we work to rapidly validate AEROSURF technology in addition to including a dosing regimen that delivers more surfactant in a shorter period of time. We believe this study, if successful, will finalize our Phase 2 data package and position the program to transition into Phase 3 clinical development studies."

The AEROSURF Phase 2b bridging study (ClinicalTrials.gov ID# NCT04264156) is a multicenter, randomized, controlled study with masked treatment assignment in up to 90 premature infants 26 to 32 weeks gestational age (GA) receiving nasal continuous positive airway pressure (nCPAP) for RDS. The trial will leverage AEROSURF's favorable safety profile from the previous Phase 2 studies to deliver more surfactant in a shorter period of time and evaluate the effect on nCPAP failure compared to premature infants receiving standard care of nCPAP alone. The trial will utilize Windtree's new aerosol delivery system (ADS) technology and bridge to data generated in the Phase 2 program utilizing a prototype device on the following endpoints: incidence of nCPAP failure (the need for intubation and delayed surfactant therapy), time to nCPAP failure and physiological parameters indicating the effectiveness of lung function. If successful, this bridging study is intended to complete the Phase 2 clinical program for AEROSURF and prepare to transition clinical development to Phase 3 development.

Steve Simonson, M.D., chief medical officer of Windtree, added, "The primary clinical objective of the AEROSURF program is to effectively treat RDS by delivering our KL4 surfactant non-invasively in order to avoid the complications associated with traditional, invasive administration. Unfortunately, intubation and traditional surfactant delivery are associated with potentially detrimental physiological changes. In parallel with evaluating the new aerosol delivery system and our RDS treatment, some patients can be enrolled in a concomitant study being run at select sites that we believe may demonstrate additional potential benefits of a non-invasive approach to treating RDS in these fragile infants."

Invasive administration of surfactant may be complicated by transient airway obstruction, oxygen desaturation, bradycardia, blood pressure changes and alterations in cerebral blood flow and brain electrical activity. The newly announced investigator-sponsored study will simultaneously measure cerebral tissue oxygenation with near-infrared spectroscopy and amplitude-integrated EEG in infants receiving non-invasive surfactant delivery with AEROSURF and will be compared to infants who have required invasive surfactant administration. This study plans to enroll up to 10-12 premature infants that are taking part in the AEROSURF Phase 2b study. Data is expected in tandem with the AEROSURF Phase 2b study.

About AEROSURF
AEROSURF® (lucinactant for inhalation) is an investigational combination drug/medical device product that Windtree is developing to improve the management of RDS in premature infants who may not have fully-developed natural lung surfactant and may require surfactant therapy to sustain life. AEROSURF is designed to deliver aerosolized KL4 surfactant noninvasively using our proprietary ADS technology and potentially may meaningfully reduce the use of invasive endotracheal intubation and mechanical ventilation. The Company believes that AEROSURF, if approved, may meaningfully reduce the number of premature infants who are subjected to invasive surfactant administration, and potentially provide transformative clinical and pharmacoeconomic benefits. The FDA has granted Fast Track designation for AEROSURF to treat RDS.

About Windtree Therapeutics
Windtree Therapeutics, Inc. is a clinical-stage, biopharmaceutical and medical device company focused on the development of novel therapeutics intended to address significant unmet medical needs in important acute care markets. Windtree has three lead clinical development programs spanning respiratory and cardiovascular disease states, including istaroxime, a novel, dual-acting agent being developed to improve cardiac function in patients with acute heart failure and cardiogenic shock; AEROSURF®, an innovative combination drug/device product candidate that is designed to deliver the Company's proprietary synthetic, peptide-containing surfactant noninvasively to premature infants with respiratory distress syndrome (RDS); and rostafuroxin, a novel precision drug product being developed to target hypertensive patients with certain genetic profiles in the important group of patients with resistant hypertension. Windtree also has multiple pre-clinical programs, including potential heart failure therapies delivered orally that are based on SERCA2a mechanism of action.

For more information, please visit the Company's website at www.windtreetx.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The Company may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are based on information available to the Company as of the date of this press release and are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company's current expectations. Examples of such risks and uncertainties include: risks and uncertainties associated with the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the Company's clinical trials or disruption in supply chain; the success and advancement of the clinical development programs for istaroxime, AEROSURF® and the Company's other product candidates; the Company's ability to secure significant additional capital as and when needed; the Company's ability to access the debt or equity markets; the Company's ability to manage costs and execute on its operational and budget plans; the results, cost and timing of the Company's clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; risks related to technology transfers to contract manufacturers and manufacturing development activities; delays encountered by the Company, contract manufacturers or suppliers in manufacturing drug products, drug substances, aerosol delivery systems (ADS) and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including that: (i) the FDA or other regulatory authorities may not agree with the Company on matters raised during regulatory reviews, 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 the Company's product candidates, and (ii) changes in the national or international political and regulatory environment may make it more difficult to gain regulatory approvals and risks related to the Company's efforts to maintain and protect the patents and licenses related to its product candidates; risks related to the size and growth potential of the markets for the Company's product candidates, and the Company's ability to service those markets; the Company's ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; and the rate and degree of market acceptance of the Company's product candidates, if approved. These and other risks are described in the Company's periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

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SOURCE Windtree Therapeutics, Inc.