Windtree Therapeutics, Inc. has announced a strategic partnership with New Growth Advisors (NGA) to explore potential out-licensing or asset sale opportunities for its cardiovascular portfolio, with a focus on istaroxime. This decision follows promising Phase 2 clinical trial results of istaroxime in early cardiogenic shock and acute heart failure.
The collaboration aims to leverage NGA's expertise in life sciences consulting to secure non-dilutive funding for istaroxime and next-generation, oral SERCA2a activators, excluding the Greater China territory. NGA will manage existing interest and conduct an expanded out-licensing process.
Istaroxime's Clinical Potential
Istaroxime is a first-in-class dual-mechanism therapy designed to improve both systolic and diastolic cardiac function. It acts as a positive inotropic agent by inhibiting Na+/K+-ATPase, increasing myocardial contractility, and facilitates myocardial relaxation through activation of the SERCA2a calcium pump, enhancing calcium reuptake. Clinical data from Phase 2 studies in early cardiogenic shock and acute decompensated heart failure have demonstrated that intravenous istaroxime significantly improves cardiac function and blood pressure without increasing heart rate or causing cardiac rhythm disturbances.
Jed Latkin, CEO of Windtree, stated, "It seems that there has been a heightened focus on cardiovascular assets and programs by the larger pharmaceutical companies and with our four positive Phase 2 istaroxime studies, including the recent positive Phase 2b SEISMiC study in early cardiogenic shock, we believe it is a good time to run a rigorous outreach and process with an experienced, well-connected business development advisor."
Strategic Implications for Windtree
Windtree currently has a licensing agreement with Lee’s Pharmaceuticals for istaroxime in the Greater China territory, potentially yielding up to $138 million in milestones and royalties. Lee’s Pharmaceuticals is responsible for all development costs and plans to initiate Phase 3 trials in acute heart failure in the first half of 2025.
If a deal is consummated, Windtree intends to use the proceeds to advance its novel, preclinical oncology platform and further develop its cardiovascular program with a partner. This strategic move reflects a focus on maximizing the value of its assets and diversifying its pipeline.
About Windtree Therapeutics
Windtree Therapeutics is a biotechnology company focused on developing innovative therapies for critical conditions and diseases. Its portfolio includes istaroxime for acute heart failure and cardiogenic shock, preclinical SERCA2a activators for heart failure, and preclinical precision aPKCi inhibitors for oncology applications.
