WELCOME TO WINDTREE THERAPEUTICS

Delivering Innovative Treatment and Hope for Patients in Their Moments of Crisis

We are 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. Our development programs are primarily focused on the treatment of acute cardiovascular and acute pulmonary diseases in areas with high unmet needs; 2 programs have Fast-Track designation. We are developing istaroxime as a first-in-class treatment for acute heart failure and early cardiogenic shock. We are evaluating lucinactant (KL4 surfactant) in adults with COVID-19 associated lung injury who are intubated and on mechanical ventilation in an intensive care unit. We are also developing AEROSURF®, a drug-device combination to aerosolize lucinactant, in partnership with our licensee in Asia, as a non-invasive treatment for premature infants with respiratory distress syndrome (RDS).

 

Our lead acute cardiovascular product candidate, istaroxime, is a first-in-class, dual-acting agent being developed to improve cardiac function in patients with acute heart failure, or AHF, with a potentially differentiated safety profile from existing treatments. Lucinactant is a synthetic KL4 surfactant, structurally similar to human pulmonary surfactant. In COVID-19 patients, we believe lucinactant may mitigate the surfactant abnormalities that can occur in severe lung injury potentially limiting lung damage, improving oxygenation and lung compliance, and reducing time on mechanical ventilation or days in the intensive care unit. AEROSURF® is drug-device combination that incorporates lucinactant and a proprietary aerosol delivery system to non-invasively deliver surfactant to premature infants suffering from RDS, a complication resulting from inadequate surfactant production. In all we do, we are driven by compassion and the aspiration to help patients and their families navigate unexpected medical crises to provide hope for a life less impacted by disease.

Istaroxime is a firstinclass dual mechanism therapy designed to improve cardiac function by increasing both systolic contractions of the heart as well as diastolic relaxation through SERCA2a activation and Na+/K+ ATPase inhibition.

Lucinactant (KL4 surfactant) is structurally similar to human pulmonary surfactant but is synthetic. We are studying lucinactant dosed as a liquid instillate in a small Phase 2 pilot study to assess its ability to impact key respiratory parameters in the treatment of lung injury and acute respiratory distress syndrome, or ARDS, COVID-19 infections

AEROSURF® is drug-device combination that incorporates lucinactant to treat premature infants suffering from RDS, a complication with preterm births due to the infant’s lungs lacking endogenous surfactant. AEROSURF® allows the healthcare professional to non-invasively deliver surfactant using Windtree’s proprietary aerosol delivery system (ADS) in order to avoid common complications associated with invasive administration, intubation and ventilation.

“Our mission is clear – to support patients in crisis situations by arming the healthcare providers with therapies that significantly improve upon current standards of care. We are developing important critical care innovations that have the potential to address some of the most significant unmet medical needs and will strive to deliver them responsibly with unrelenting attention to quality and access to care.”

— Craig Fraser