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WINT: Advancing Two Lead Fast Track-Designated Drug Candidates Toward Approval & Commercialization

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By M. Marin



We are initiating coverage of Windtree Therapeutics, Inc. (NASDAQ:WINT), 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 due to heart failure, respiratory distress syndrome (RDS) in premature babies and other lung injuries. The company’s multiple late-stage assets and programs are focused on important markets with high unmet needs. With recent successful financings and an uplisting to Nasdaq, the company is executing on a number of clinical programs and activities that have the potential for important milestones and potential catalysts. WINT’s two lead assets, istaroxime and AEROSURF, both have FDA Fast Track designation.

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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 is advancing istaroxime, which has a potentially differentiated safety profile versus existing AHF therapies, for the treatment of AHF to a Phase 3-ready position.

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Given the observed significant improvements to blood pressure, istaroxime is also being studied in AHF patients suffering from early cardiogenic shock for which there is substantial unmet medical need. WINT believes that successful results of clinical studies could lead to the FDA granting Breakthrough Designation for istaroxime treatment of early cardiogenic shock.

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.

COVID-19 Treatment Could Provide Data on AEROSURF Efficacy for Treatment of Lung Injury Generally

WINT has also produced substantial pre-clinical data in a variety of lung injury models beyond RDS and intends to apply this knowledge and KL4 surfactant’s potential to mitigate lung injury in a small study in COVID-19 patients in 2H20. The virus that causes COVID-19 infections can also destroy surfactant-producing cells within the lungs. WINT is working through the investigational new drug (IND) application process with the FDA for an initial pilot clinical trial in the U.S. to assess the impact of non-aerosolized KL4 surfactant on key respiratory parameters in ventilated COVID-19 patients to show the physiologic improvements that occur when KL4 surfactant is administered. Treatment of COVID-19 could provide additional data on AEROSURF’s efficacy for treatment of lung injury generally.

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. We estimate rapid growth for both once they are commercialized and believe the current share price does not reflect the fundamental value of the company’s pipeline and prospects.

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