Windtree Therapeutics reports positive Phase 2 trial results for istaroxime.

Windtree Therapeutics has performed an interim analysis of the SEISMiC C Phase 2 study on istaroxime for treating cardiogenic shock. The study found that istaroxime had a similar profile to previous trials, with no new safety signals identified. The company is confident in moving forward with a global Phase 3 trial for the treatment.

Windtree Therapeutics, Inc. (NASDAQ: WINT) has announced positive interim analysis results from its SEISMiC C Phase 2 study evaluating istaroxime in SCAI Stage C cardiogenic shock patients. The study, conducted across the U.S., Europe, and Latin America, demonstrated that istaroxime maintained its safety profile and showed consistent physiological improvements when combined with current standard treatments.

The interim analysis of the first 20 patients enrolled in the study revealed no new safety concerns or excess arrhythmias when istaroxime was administered alongside standard therapies. This positive outcome supports Windtree's decision to advance to a global Phase 3 trial. The company expects to begin this final stage of clinical trials soon, which is a significant milestone towards potential commercialization in a therapeutic area with substantial unmet medical need.

Cardiogenic shock, a severe heart failure presentation, is associated with high mortality rates and limited effective treatment options. Istaroxime, a first-in-class dual-mechanism therapy, has shown promising results in improving both systolic and diastolic cardiac function. The drug's ability to maintain its safety profile and demonstrate consistent physiological improvements even when combined with existing medications is particularly notable.

Windtree's Chief Executive Officer, Jed Latkin, commented on the interim analysis results, stating, "We believe these data will be instrumental in moving istaroxime to a global Phase 3 program in heart failure and cardiogenic shock." Chief Medical Officer, Steve Simonson, added, "The interim data are consistent with the previous clinical study results seen in patients with AHF and less severe forms of cardiogenic shock. These data are encouraging for the potential of istaroxime to be effective across the spectrum of cardiogenic shock due to AHF with or without other inotropic or vasopressor drugs."

The SEISMiC C study builds upon previous positive results from the SEISMIC B trial, where istaroxime improved critical parameters including blood pressure, cardiac output, and organ perfusion in less severe shock patients. The consistent performance across different severity levels of heart failure suggests istaroxime may have a broad therapeutic application across the spectrum of cardiogenic shock.

Windtree's interim analysis of istaroxime in SCAI Stage C cardiogenic shock shows promising results in a patient population with greater disease severity than previously studied. The drug maintained its established safety profile even when combined with current standard treatments, with no new safety signals identified. This is particularly significant as cardiogenic shock represents a severe heart failure presentation with high mortality rates and limited effective treatment options.

The consistent performance across different severity levels of heart failure suggests istaroxime may have a broad therapeutic application across the spectrum of cardiogenic shock. These interim data provide sufficient confidence for Windtree to advance to a global Phase 3 program, the final stage before potential regulatory submission.

Windtree Therapeutics, Inc. is a diversified company with several divisions, including a cryptocurrency treasury strategy and two promising therapeutic pipelines for which the Company is actively seeking long-term development partners. The company's interim analysis of istaroxime in SCAI Stage C cardiogenic shock shows promising results in a patient population with greater disease severity than previously studied. The drug maintained its established safety profile even when combined with current standard treatments, with no new safety signals identified. This is particularly significant as cardiogenic shock represents a severe heart failure presentation with high mortality rates and limited effective treatment options.

The consistent performance across different severity levels of heart failure suggests istaroxime may have a broad therapeutic application across the spectrum of cardiogenic shock. These interim data provide sufficient confidence for Windtree to advance to a global Phase 3 program, the final stage before potential regulatory submission.

Windtree Therapeutics, Inc. is a diversified company with several divisions, including a cryptocurrency treasury strategy and two promising therapeutic pipelines for which the Company is actively seeking long-term development partners. The company's interim analysis of istaroxime in SCAI Stage C cardiogenic shock shows promising results in a patient population with greater disease severity than previously studied. The drug maintained its established safety profile even when combined with current standard treatments, with no new safety signals identified. This is particularly significant as cardiogenic shock represents a severe heart failure presentation with high mortality rates and limited effective treatment options.

The consistent performance across different severity levels of heart failure suggests istaroxime may have a broad therapeutic application across the spectrum of cardiogenic shock. These interim data provide sufficient confidence for Windtree to advance to a global Phase 3 program, the final stage before potential regulatory submission.

References:
[1] https://www.stocktitan.net/news/WINT/windtree-announces-istaroxime-phase-2-interim-analysis-in-scai-stage-tq3utcfhxoi6.html