Windtree's cardiogenic shock drug boosts blood pressure in phase 2 success

Windtree Therapeutics, a biotech company, has faced significant financial challenges but recently achieved a notable milestone with its lead asset, istaroxime. This steroidal drug has already demonstrated its ability to raise blood pressure in a Phase 2 trial reported in April 2022. Windtree announced that istaroxime achieved similar results in an extension study.

The Phase 2b SEISMiC extension trial focused on the effects of istaroxime on patients in the early stages of cardiogenic shock, a critical condition where the heart fails to pump sufficient blood to meet the body's needs. The study reached its primary goal by showing a "significant" improvement in systolic blood pressure over six hours compared to a placebo. Unlike the previous trial in 2022, which tested treatments lasting less than 24 hours, this study evaluated infusions of istaroxime for up to 60 hours. Windtree also aimed to demonstrate that istaroxime is not linked to cardiac arrhythmias, a term for irregular heartbeats, which could be a significant advantage over current drug therapies.

The announcement was sparse on specific data, which Windtree plans to reveal at the Heart Failure Society of America Meeting next week. Despite the positive trial results, investor reaction was lukewarm, leading to a 10% drop in Windtree's stock price to $2.92 when markets opened on Wednesday.

Craig Fraser, CEO of Windtree, emphasized the critical need for innovative drug solutions for cardiogenic shock, a condition associated with high morbidity and mortality. "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 stated. He expressed enthusiasm for sharing the study details and advancing istaroxime towards Phase 3 readiness for cardiogenic shock.

This latest development comes amidst ongoing financial instability for Windtree. The company started 2024 by exploring strategic alternatives, which could include potential acquisitions, mergers, company sales, or other transactions. In July, Windtree secured $12.9 million through new funding and the cancellation of outstanding senior notes and series B preferred shares. However, with a net loss of $12 million in the second quarter and only $1.8 million in cash and equivalents at the end of June, the company acknowledged last month that it lacks sufficient funds to sustain operations for at least the next 12 months.

Despite the financial struggles, the Phase 2b trial success provides a glimmer of hope for Windtree Therapeutics. The company remains committed to progressing istaroxime towards Phase 3 readiness and continues to seek strategic solutions to stabilize its financial footing. The upcoming presentation at the Heart Failure Society of America Meeting will be crucial in detailing the study results and potentially garnering further interest and support for istaroxime’s development.