By M. Marin

NASDAQ:WINT

READ THE FULL WINT RESEARCH REPORT

Multiple Programs Focus on Unmet Needs In Cardiogenic Shock & AHF

Pennsylvania-based Windtree Therapeutics, Inc. (NASDAQ:WINT) is a biopharmaceutical company developing therapies for a range of cardiovascular and oncology treatments characterized by significant unmet need. The company’s lead indication area is cardiogenic shock (which is a severe form of heart failure). The company’s lead asset, Istaroxime, is a first-in-class, dual-acting agent being developed to improve blood pressure and cardiac function in patients with cardiogenic shock. A second indication is treatment of acute heart failure by improving cardiac function.

Lead Asset Istaroxime has Fast Track Therapy Designation

Istaroxime has been granted FDA Fast Track designation for the treatment of AHF. Fast track could lead to an expedited FDA review of istaroxime to treat AHF, potentially shortening the clinical timeline and time to commercialization. Once an asset receives Fast Track designation, it is potentially eligible for, among other factors:

• More frequent communication and meetings with the FDA to discuss development plans
• Accelerated approval and priority review depending on when/if relevant criteria are met

Windtree recently reported positive Phase 2b clinical trial data in early cardiogenic shock. To position istaroxime for Phase 3 readiness, WINT is also enrolling a small Phase 2 study in SCAI Stage C, administering istaroxime to patients with the more severe form of cardiac shock, SCAI Stage C. WINT is also developing next generation therapies called SERCA2a activators in areas for acute and chronic cardiovascular disease.

The trial evaluated two different dose regimens of istaroxime compared to placebo. Patients received infusions of istaroxime for up to 60 hours. By comparison, treatment in prior studies was limited to 24 hours. The extended treatment time was designed to determine the potential for additional benefit at longer dosing. The trial had one cohort that received a decreasing istaroxime dose over the period and the other cohort received a constant istaroxime dose. It aggregated data related to both cardiac and renal function and additional safety information on cardiac arrhythmias. Importantly, the study results were consistent with results of prior clinical activity, indicating that istaroxime is not related to increased cardiac arrhythmias. WINT believes this is a potentially important differentiating characteristic compared to commonly used current drug therapies.

Study met its primary endpoint

• The study met its primary endpoint in significantly improving systolic blood pressure over six hours (SBP AUC), with the combined Part A and Part B SEISMiC istaroxime group performing significantly better compared to the placebo group (62.0±7 vs 36.4±7 mmHg*hr, p = 0.0070). Despite the smaller number of patients in SEISMiC Part B, the SBP AUC was also significantly improved by istaroxime compared to placebo (78.4±12 vs. 39.6±14 mmHg*hr, p=0.0429).
• The improvements in SBP AUC at 24 hours in the combined Part A and Part B analysis were also significantly increased by istaroxime (292.4±24 vs 190.9±26 mmHg*hr, p=0.0031). In Part B alone, the istaroxime group was significantly better compared to the placebo group (299.3±48 vs 139.0±56 mmHg*hr, (p = 0.0377). With the longer istaroxime dosing in Part B, the SBP AUC was significantly improved at 48 hours (594.4±95 vs 271.7±110, p = 0.0352) and 60 hours (711.4±119 vs 320.4±138 mmHg*hr, p = 0.0408) as well.

KOLs, Cardiologists Support WINT’s Optimism

The results of this latest study augment the company’s growing istaroxime database, which WINT believes supports its confidence that istaroxime could be a better way to treat AHF and cardiac shock patients. Moreover, WINT’s scientific board and numerous KOLs are optimistic about the prospects for istaroxime. Of 100 cardiologists surveyed, 84% indicated that they would be ‘likely to extremely likely’ to use istaroxime for early cardiogenic shock patients. Moreover, most indicated they would prioritize istaroxime before using other existing classes of therapies such as inotropes and vasopressors.

New strategy to use shares to acquire FDA approved revenue generating assets

Under new CEO Jed Latkin, the company has recently embarked on a new strategy to acquire small biotechs with FDA approved assets to become a revenue generating biotech. The company intends to continue to develop its existing cardiovascular and oncology pipeline (see below). Windtree plans to become a parent company acquiring strategic subsidiaries with FDA-approved products and believes its management team has commercialization expertise in both large pharmaceutical and small biotech companies across multiple therapeutic areas. WINT expects that it will be able to leverage synergies among and optimize performance of potential acquired subsidiaries. WINT believes it can improve sales and lower costs and intends to use equity to acquire new subsidiaries. Management is optimistic that this new strategy can be transformative.

Windtree expects multiple potential upcoming milestones

• Planned interim analysis of Istaroxime cardiogenic shock SCAI Stage C Phase 2 study for early 2Q25
• Potential type C meeting with the FDA for the back half of 2025
• The company’s istaroxime regional licensing partner for greater China, Lee’s Pharma, plans to begin an istaroxime acute heart failure Phase 3 program in its licensed territory
• Lee’s Pharma is responsible for the costs of the study
• WINT is collaborating with its partner and has final say on the study protocol
• Potential business development partnership with cardiovascular portfolio
• Potential acquisitions of revenue ready FDA approved assets

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