Windtree Therapeutics (WINT) Releases Data from Lung Deposition Study Conducted in Non-Human Primates

October 24, 2016 5:32 PM EDT
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Windtree Therapeutics, Inc. (Nasdaq: WINT), a biotechnology company focused on developing aerosolized KL4 surfactant therapies for respiratory diseases, today released data from a lung deposition study conducted in non-human primates (NHPs) that demonstrates the Company's proprietary aerosol delivery system (ADS) is capable of delivering aerosolized KL4 surfactant throughout all regions of the lung. The study consisted of a series of experiments in NHPs designed to assess the distribution and deposition of aerosolized KL4 surfactant in the lung when administered using the ADS. The Company is developing the ADS as part of its lead development program, AEROSURF® (lucinactant for inhalation). AEROSURF is currently being studied in a phase 2b clinical trial as a potential noninvasive treatment for respiratory distress syndrome (RDS) in premature infants. The Company will host a conference call and live webcast on Tuesday, October 25, 2016 at 8:00 a.m. EDT to provide additional details of the study results as well as provide an update on the AEROSURF phase 2 program.

"These study results confirm the ability of our aerosol delivery technology to overcome the barriers of successfully aerosolizing and delivering a surfactant with particle sizes appropriate for deep lung delivery with uniform distribution across all regions of the lung," commented Craig Fraser, President and Chief Executive Officer. "These results not only support the premise of our AEROSURF RDS program, but also complement the clinical evidence seen in our phase 2a trial in premature infants 29 to 34 week gestational age and provide further insight into other potential applications of this novel technology in the future."

Data from this study were generated from an in vivo distribution study using three NHPs, cynomolgus macaques, which received three-to-ten minute exposures of technetium-labeled KL4 surfactant that was aerosolized using the same model ADS currently being used in the AEROSURF phase 2b clinical program. After administration, researchers immediately acquired 2-D planar images followed by 3-D SPECT images 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 KL4 surfactant, delivered using the ADS via constant flow nasal continuous positive airway pressure (nCPAP), was generally uniformly deposited in all regions of the NHPs lungs (Image 1 – right).

Results from a quantitative analysis further demonstrated that there was generally uniform distribution in all regions of the lung, with an average total lung distribution of 52 percent in the five inner shells and 48 percent in the five outer shells (Chart 1 – right).

"We are extremely pleased with the results of this study because, along with other work we have done, it serves as yet another validation of the potentially transformational capabilities of our ADS device, which aerosolizes our KL4 surfactant in a consistent and controlled flow and delivers it throughout the lungs to the areas where a surfactant needs to reach to produce its beneficial effects," commented Steve Simonson, M.D, Senior Vice President and Chief Development Officer.

Conference Call and Webcast DetailsThe Company will host a conference call and webcast (including a slide presentation) at 8:00 a.m. EDT on Tuesday, October 25, 2016 to provide updates on the AEROSURF® phase 2 clinical program and the lung deposition study in non-human primates.

To participate in the live call and take part in the question and answer session, dial (844) 802-2436 (domestic) or (412) 317-5129 (international). The live webcast, including a slide presentation, can be accessed at http://windtreetx.investorroom.com/events.

A replay of the conference call will be accessible one hour after completion through November 1, 2016 by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and referencing conference number 10095419. An archive of the webcast can be accessed on the Company's website at http://windtreetx.investorroom.com/events.



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