Windtree's phase 2 shock med rapidly raises blood pressure—and share price

Windtree Therapeutics’ cardiogenic shock medicine istaroxime rapidly raised systolic blood pressure in patients with the life-threatening condition, meeting the main goal of a phase 2 study and sending the small biotech’s shares climbing nearly 40% as the markets opened Wednesday.

The study, called Seismic, tested istaroxime in 60 patients with cardiogenic shock, which is when the body suddenly cannot pump enough blood to meet the body’s needs. This is typically caused by a heart attack but not always. The patients in the trial had experienced severe heart failure and had systolic blood pressure between 75 mmHg and 90 mmHg.

Istaroxime was infused for 24 hours at two different doses, but the data was combined for the analysis to compare to placebo. The study met its goal of improving systolic blood pressure profile over six hours in patients who received Windtree’s med.

Secondary goals, which the company did not yet report, include systolic and diastolic cardiac function, renal function and safety and tolerability. Further results will be presented next month at the European Society of Cardiology Heart Failure meeting.

The company was mostly mum on its exact next steps, although President and CEO Craig Fraser did say the company would meet with regulatory agencies “to further define a potential development path to approval.”

Windtree’s shares gained about 39 cents, landing at $1.39, compared to a prior close of 98 cents.

Istaroxime is also being developed in acute heart failure. The company has several other meds in development, including lucinactant for treating lung injury in COVID-19 patients. The therapy is currently in phase 2.