WARRINGTON, PA — Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotech firm based in Bucks County, has shared significant updates on its novel heart failure therapy, istaroxime. This therapy aims to improve heart function and has shown promising results in early trials.
Istaroxime is designed to enhance both the contraction and relaxation phases of the heartbeat. It also helps manage blood pressure and supports kidney function. The drug has already demonstrated positive outcomes in three Phase 2 trials involving patients with acute heart failure and early cardiogenic shock.
The company’s Phase 2 SEISMiC Extension Study, focusing on patients with early cardiogenic shock, is nearing completion. Windtree expects to finish enrolling patients in the next few weeks and aims to release initial data by the end of the quarter. This study seeks to fine-tune the drug’s dosage and further understand its effects, particularly on the SERCA2a mechanism, a key factor in heart function.
In this study, patients receive istaroxime infusions for up to 60 hours. One group receives a decreasing dose over time, while another group gets a consistent dose. The goal is to extend the dosing period compared to earlier trials, where treatment lasted only 24 hours. Windtree believes that a longer dosing duration could offer greater benefits and help determine the best dosage for future trials. The study also looks at how istaroxime affects heart function and blood pressure, with no increase in cardiac arrhythmias observed so far.
Windtree is also preparing to start a parallel study for more severe cases of cardiogenic shock, known as SCAI Stage C. This study will involve up to 20 patients and will compare istaroxime with a placebo. Patients will receive the drug alongside standard treatments for six hours, after which these treatments will be stopped. The primary goal is to assess changes in systolic blood pressure. Other key measures include time to treatment failure, length of hospital stay, and changes in heart function.
The company’s progress extends beyond clinical trials. In January, Windtree signed a license agreement with Lee’s Pharmaceutical for the development and commercialization of istaroxime in Greater China. This deal also includes Windtree’s preclinical SERCA2a activators and a hypertension drug candidate, rostafuroxin. The agreement could bring Windtree up to $138 million in future milestones, plus royalties, and covers all costs for development and commercialization in the licensed region.
Craig Fraser, CEO and Chairman of Windtree Therapeutics, expressed optimism about these developments. “We are pleased with our progress in clinical development because of the importance of the high unmet needs in the patient populations we are studying,” he said. Fraser also highlighted the value of the partnership with Lee’s Pharmaceutical in advancing the program for acute heart failure in Greater China.
As Windtree continues its clinical trials and prepares for future phases, the company remains focused on addressing the critical needs of heart failure patients worldwide.
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