Windtree Therapeutics, Inc. announced that its preclinical stage drug candidates called SERCA2a Activators were featured in a publication in The Journal of Pharmacology and Experimental Therapeutics entitled "Istaroxime Metabolite PST3093 Selectively Stimulates SERCA2a and Reverses Disease-Induced Changes in Cardiac Function." Heart failure is a complex and heterogeneous condition and involves impaired ability of the heart to contract (systolic) and/or relax (diastolic function). The publication emphasizes the interest in SERCA2a as a target in treating heart failure because it is instrumental in calcium management, critically important in heart muscle contraction and relaxation. It has been difficult to achieve, however, approach to relieve the inhibition of SERCA2a by phospholamban has provided a potentially successful mechanism to achieve this goal. Human clinical data emerging from the istaroxime program is substantiating this approach and providing unique insight into the potential benefits of this mechanism in humans. Istaroxime has completed three positive phase 2 clinical studies in acute decompensated heart failure and early cardiogenic shock. This experience may provide a better probability for clinical success in the development of SERCA2a activators as they advance. Additionally, the USPTO published the Company's SERCA2a Activator patent application entitled "Androstane Derivatives with Activity as Pure or Predominantly Pure Stimulators of SERCA2a for the Treatment of Heart Failure." Sarco endoplasmic reticulum Ca2+ -ATPase 2a, or SERCA2a, activators increase SERCA2a activity. The Windtree research program is evaluating these preclinical product candidates as oral and intravenous SERCA2a activator heart failure compounds. As potential oral agents, these candidates could be used for chronic treatment of heart failure. Istaroxime is a first-in-class dual mechanism therapy designed to improve both systolic and diastolic cardiac function. Istaroxime is a positive inotropic agent that increases myocardial contractility through inhibition of Na+/K+- ATPase with a complimentary mechanism that facilitates myocardial relaxation through activation of the SERCA2a calcium pump on the sarcoplasmic reticulum enhancing calcium reuptake from the cytoplasm. Data from multiple 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.