Windtree Therapeutics Announces Publication of Results of Lung Deposition Study of Aerosolized Lucinactant

WARRINGTON, Pa., Sept. 6, 2019 /PRNewswire/ -- Windtree Therapeutics, Inc. (Formerly Known As Discovery Laboratories, Inc.),  (OTCQB: 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 the full publication of previously described results of a lung deposition study conducted in non-human primates (NHPs) that demonstrated the Company's proprietary aerosol delivery system (ADS) is capable of delivering aerosolized lucinactant (the Company's lyophilized KL4 surfactant) throughout all regions of the lung. The study was performed in collaboration with Lovelace Biomedical and is published in the Journal of Aerosol Medicine and Pulmonary Drug Delivery. The study consisted of a series of experiments in NHPs designed to assess the distribution and deposition of aerosolized lucinactant in the lung when administered using the ADS. The Company has developed the ADS as part of its AEROSURF® (lucinactant for inhalation) development program. AEROSURF is currently being studied in a phase 2 clinical program as a potential noninvasive treatment for respiratory distress syndrome (RDS) in premature infants.  The article titled, "Deposition of Aerosolized Lucinactant in Nonhuman Primates", is now available on the journal website.

"The publication of this study in a peer-reviewed journal as prestigious as the Journal of Aerosol Medicine and Pulmonary Drug Delivery validates the scientific rigor of our study and the importance of the results which demonstrate the capabilities of our aerosol delivery technology," commented Dr. Steve Simonson, Senior Vice President and Chief Medical Officer. "These data complement the results of our phase 2 clinical program evaluating AEROSURF for the treatment of RDS and substantiate our use of these technologies (lucinactant and ADS) to deliver lucinactant and potentially other therapeutics to achieve uniform delivery and distribution throughout the lungs."

Data were generated from an in vivo distribution study using three NHPs, cynomolgus macaques (no animals were sacrificed in this study), which received three-to-ten minute exposures of technetium-labeled KL4 surfactant that was aerosolized using the same model ADS that was used in the AEROSURF phase 2 clinical program. After administration, researchers immediately acquired a 2-D planar image followed by a 3-D SPECT image and then a second 2-D planar image to assess overall pulmonary distribution. Additionally, the 3-D SPECT lung data were analyzed using a quantitative methodology whereby regional distribution was assessed across ten equally-sized shells (or layers) of the lung, from the innermost shell through the outermost shell. Results from the analysis of the 2-D planar and 3-D SPECT images show that aerosolized lucinactant, delivered using the ADS via constant flow nasal continuous positive airway pressure (nCPAP), was generally uniformly deposited in all regions of the NHPs' lungs. Results from a quantitative analysis further also demonstrated that distribution was generally uniform throughout all regions of the lung, with an average total lung distribution of 53 percent in the five inner shells and 47 percent in the five outer shells. These results demonstrated that aerosolized lucinactant, delivered using the ADS via constant flow nCPAP, is deposited in all regions of the lungs.

About AEROSURF®
AEROSURF (lucinactant for inhalation) is a novel, investigational combination drug/device product that combines Windtree's proprietary KL4 surfactant and aerosolization technologies.  AEROSURF is being developed to potentially reduce the need for endotracheal intubation and mechanical ventilation in the treatment of premature infants with respiratory distress syndrome (RDS). AEROSURF has received Fast Track designation from the Food and Drug Administration (FDA). The purpose of Fast Track designation is to facilitate the development and expedite the review and potential approval of new drugs to treat serious and life-threatening conditions and that have demonstrated the potential to address an unmet medical need.

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 clinical development programs and multiple pre-clinical programs spanning respiratory and cardiovascular disease states, including istaroxime, a novel, dual-acting agent with a potentially improved side-effect profile compared to existing treatments, being developed to improve cardiac function in patients with acute heart failure; AEROSURF®, an innovative combination drug/device product candidate that is designed to deliver the Company's proprietary synthetic, peptide-containing surfactant non-invasively 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 products 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
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 the post-merger integration of CVie Therapeutics Limited, including with respect to having two international locations; risks related to Windtree's ability to secure significant additional capital as and when needed, if at all, or to access debt or equity financings, which could result in substantial equity dilution; risks related to Windtree's product development programs, which are expected to involve time-consuming and expensive pre-clinical studies and  clinical trials and which may be subject to potentially significant delays or regulatory holds, or fail; risks related to development of Windtree's aerosol delivery systems (ADS) and related components; risks related to technology transfers to contract manufacturers and manufacturing development, and problems or delays encountered by Windtree, 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 those of the U.S. Food and Drug Administration or other regulatory authorities that may not agree with Windtree on matters raised during regulatory reviews, or 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; changes in the national or international political and regulatory environment may make it more difficult to gain regulatory approvals; risks related to Windtree's efforts to maintain and protect the patents and licenses related to its 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.