While Windtree Therapeutics has struggled to grow the financial roots needed to survive, a phase 2 win for the biotech’s lead asset will at least give the company encouragement to persevere.
The steroidal drug, called istaroxime, has already been shown to help raise blood pressure in a phase 2 trial that read out in April 2022, and this morning Windtree announced that the candidate had managed the same feat in an extension study.
The phase 2b SEISMiC extension trial was looking at the effects of using istaroxime to treat patients in the early stages of cardiogenic shock, a medical emergency where the heart suddenly stops pumping enough blood for the body’s needs. The study achieved the primary endpoint of demonstrating a “significant” improvement in systolic blood pressure over six hours when compared to placebo.
Unlike the previous SEISMiC study in 2022 that tested treatment that lasted under 24 hours, this time Windtree evaluated infusions of istaroxime for up to 60 hours. The trial was also a chance to show that istaroxime isn’t linked to cardiac arrhythmias—a term for irregular heartbeat—which Windtree said could be a “potentially important differentiating characteristic compared to commonly used current drug therapies.”
The release was light on data, which the company said it would unveil at the Heart Failure Society of America Meeting next week. The topline win didn’t seem enough to enthuse investors, who sent Windtree’s stock down 10% to $2.92 when the markets opened Wednesday morning.
“Cardiogenic shock is a critical condition with high morbidity and mortality where clinicians note a high need for new drug innovation,” Windtree CEO Craig Fraser said in the release.
“Across four phase 2 studies to date, istaroxime has demonstrated a highly unique and attractive profile as a potential therapy for cardiogenic shock and acute heart failure patients,” Fraser added. “We are excited to share the details of study results next week and to continuing to progress istaroxime towards phase 3 readiness for cardiogenic shock.”
The latest readout comes amid ongoing financial instability for the company. Windtree kicked off 2024 with a search for strategic alternatives that could have stretched to a potential acquisition, merger, company sale or other transaction.
Windtree did have some good news in July when it brought in $12.9 million via a combination of new funding and canceling outstanding senior notes and series B preferred shares. Still, with a net loss of $12 million in the second quarter and just $1.8 million on hand in cash and equivalents as of the end of June, the company admitted last month that it doesn’t have enough money “to support our operations for at least the 12 months following the date that the financial statements are issued.”