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WINT: Clinical Studies Moving Forward For Both Lead Treatment Programs

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By M. Marin



Two Lead Drug Candidates; Multiple Programs

Windtree Therapeutics, Inc. (NASDAQ:WINT) is a biopharma and medical device company developing therapies for a range of acute cardiovascular and pulmonary conditions that necessitate critical care, including acute heart failure (AHF), cardiogenic shock (CS) due to heart failure, respiratory distress syndrome (RDS) in premature babies and other lung injuries, including lung injury caused by COVID-19. The company’s multiple late-stage assets and programs are focused on important markets with high unmet needs. WINT’s two lead assets, istaroxime and AEROSURF, both have FDA Fast Track designation and the company is optimistic about potential Breakthrough designation for istaroxime.

Istaroxime CS Study

WINT’s clinical studies are moving forward. Given the observed significant improvements to blood pressure, istaroxime is being studied in AHF patients suffering from early cardiogenic shock for which there is substantial unmet medical need. WINT dosed the first patient in its Phase 2 istaroxime study in patients with early CS last month. WINT is optimistic that istaroxime's dual mechanism of action (illustrated below) could be critical in treating and stabilizing patients with severe AHF. In addition to study programs currently underway, WINT plans extension studies of both drug/treatment candidates down the road.

WINT’s istaroxime Phase 2 study is an international randomized double blind placebo controlled study to assess istaroxime efficacy in treating patients with early CS due to heart failure. The study will include 60 patients (30 of whom will be assigned to istaroxime and 30 assigned to placebo) receiving study drug infusion over 24 hours.

The primary endpoint of the study is the change in systolic blood pressure over six hours after initiating the infusion. Secondary endpoints will include:

• characterization of blood pressure changes over a 24-hour period

• number of patients requiring rescue therapy such as vasopressors, inotropes or mechanical devices

• assessment of renal function

• safety and tolerability

Istaroxime is a first-in-class dual mechanism therapy designed to improve both systolic contraction and diastolic relaxation functions of the heart. Istaroxime produces these effects by inhibiting sodium-potassium ATPase and by activation of SERCA2a. Data from two Phase 2 studies in patients with acute heart failure (AHF) demonstrate that istaroxime infused intravenously significantly improves cardiac function and blood pressure without causing heart rate increases or rhythm disturbances.

WINT believes that successful results of clinical studies could lead to the FDA granting Breakthrough Designation for istaroxime treatment of early cardiogenic shock. Breakthrough therapy designation could expedite WINT’s development program for istaroxime. There is previous FDA precedent suggesting the opportunity for breakthrough designation and a possible accelerated pathway of development and approval.

COVID-19 Study Potentially Could Lead to New Applications for KL4 surfactant / AEROSURF

AEROSURF is a drug-device combination that incorporates synthetic KL4 surfactant with an innovative, proprietary aerosol delivery system to treat premature infants with respiratory distress syndrome (RDS), a common complication with premature births due to insufficient endogenous surfactant. AEROSURF delivers surfactant non-invasively to avoid the complications frequently associated with invasive administration. Data from a phase 2 program demonstrated that AEROSURF can improve lung function and eliminate the need for intubation and mechanical ventilation in premature infants with RDS and also has the potential to impact bronchopulmonary dysplasia (BPD), a condition of chronic lung disease that has no approved therapies. WINT also intends to conduct research leveraging its AEROSURF technologies and expertise for treatment extensions.

Against the backdrop of the COVID-19 pandemic, the company also plans to study KL4 surfactant for the prevention and treatment of lung injury resulting from severe COVID-19 that frequently leads to respiratory failure and ventilator use. The COVID-19 study, expected to become operational in 4Q 2020, and growing data could lead to new applications for KL4 surfactant and potentially AEROSURF supporting efficacy for treatment of lung injury generally.

The company had cash & equivalents of $22.4 million at the end of 3Q 2020 that is expected to advance studies and fund operations through at least the next 12-months. With WINT focused on the KL4 surfactant study in COVID-19 lung Injury patients, WINT’s licensing partner, Lee's Pharmaceutical (HK), will execute the AEROSURF bridge study in premature infants with RDS and will continue to fund AEROSURF clinical development, while WINT provides technical support.

The company believes that each of its clinical programs addresses a large unmet need and provides another avenue of potential regulatory approval from the FDA. We are optimistic about the chances of istaroxime and AEROSURF receiving FDA approval and of the subsequent commercial demand of these treatment therapies.

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