Windtree Announces FDA Fast Track Designation for Istaroxime

WARRINGTON, Pa., Aug. 13, 2019 /PRNewswire/ -- Windtree Therapeutics, 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 that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for istaroxime for the treatment of acute heart failure.

"We are very pleased to receive FDA's Fast Track Designation for istaroxime. This Fast Track designation for istaroxime underscores the significant unmet medical need to treat patients suffering from acute heart failure and the potential of istaroxime as demonstrated by the phase 2 clinical results," commented Craig Fraser, President and Chief Executive Officer. "Istaroxime is a novel, dual-action agent that impacts both the systolic and diastolic function of the heart in patients hospitalized with acute heart failure. In recently announced results from a Phase 2b study evaluating istaroxime in acute heart failure patients, we achieved our primary objective of improved cardiac function, while maintaining or increasing blood pressure and decreasing heart rate during the infusion. Additionally, we observed a well characterized safety profile for Istaroxime. We look forward to continuing our work with the FDA and the cardiology community to advance istaroxime through clinical development and the regulatory approval process, with the goal of bringing to market a transformative therapy to treat acute heart failure patients."

Fast Track Designation
A drug may be granted Fast Track Designation if it is being developed for the treatment of a serious or life-threatening disease or condition and it demonstrates the potential to address an unmet medical need. The purpose of the Fast Track Designation is to facilitate the development and expedite the review and potential approval of drugs to treat serious and life-threatening conditions.

Sponsors of drugs that receive Fast Track Designation have the opportunity for more frequent communications and interactions with FDA throughout the development program. These can include meetings to discuss study design, data required to support approval, or other aspects of the clinical program. Additionally, products that have been granted Fast Track Designation may be eligible for priority review of a New Drug Application (NDA) and FDA may consider reviewing portions of an NDA before the sponsor submits the complete application (Rolling Review).

About Istaroxime
Istaroxime is a first-in-class, dual action, luso-inotropic agent in clinical development for the treatment of acute heart failure with reduced ejection fraction. Istaroxime is an intravenously administered agent with a positive inotropic agent that increases myocardial contractility through inhibition of Na+/K+-ATPase. In addition, it facilitates myocardial relaxation through activation of the SERCA2a calcium pump on the sarcoplasmic reticulum enhancing calcium reuptake from the cytoplasm.

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 and multiple pre-clinical 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 with a potentially improved side effect profile from existing treatments; 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, including projections of future cash balances and anticipated cash outflows, to differ materially from the statements made. Examples of such risks and uncertainties include: risks that Windtree will be unable to secure significant additional capital as and when needed, or to access debt or equity financings, which could result in substantial equity dilution; risks related to Windtree's development programs, which may 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 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 that: (i) the FDA or other regulatory authorities may not agree with Windtree 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 Windtree's products, and (ii) 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.