Windtree Renews Agreement with Chang Gung University for Scientific Collaboration to Further SERCA2a Research

Rhea-AI Summary

Windtree Therapeutics, Inc. renews partnership with Chang Gung University in Taiwan to further research on SERCA2a, an important target for the Company’s cardiovascular portfolio. The collaboration includes istaroxime and next-generation compounds called SERCA2a activators. Windtree believes SERCA2a activation could represent an important advancement in heart failure treatment. Istaroxime is being studied in the Phase 2 SEISMiC Extension Study in early cardiogenic shock. Market research revealed a high demand for new drug innovation to treat cardiogenic shock patients, with an estimated worldwide total market value of $1.25 billion.

Positive

• Renewal of partnership with Chang Gung University to further research on SERCA2a
• Potential advancement in heart failure treatment through SERCA2a activation
• Study of istaroxime in the Phase 2 SEISMiC Extension Study in early cardiogenic shock
• High demand for new drug innovation to treat cardiogenic shock patients
• Estimated worldwide total market value of $1.25 billion for cardiogenic shock treatment

Negative

• None.

Cardiovascular Research Scientist

Windtree Therapeutics' renewed partnership with Chang Gung University signifies a commitment to advancing the understanding and treatment of cardiovascular diseases, specifically heart failure. The focus on SERCA2a, a calcium pump involved in myocardial contraction and relaxation, is pivotal, as heart failure patients often experience reduced SERCA2a activity leading to impaired cardiac function. The preclinical stage of SERCA2a activators indicates that the company is exploring innovative avenues to treat heart failure, which may include both intravenous and oral administration methods, potentially improving patient compliance and quality of life.

Moreover, the preclinical data showing reduction in ischemia-reperfusion induced arrhythmias with istaroxime and SERCA2a activators is promising. This suggests that the compounds not only improve myocardial relaxation but may also have a protective effect against arrhythmias, a common and serious complication in heart failure patients. The therapeutic potential of these compounds could be substantial, as they address a significant unmet need in the current treatment landscape.

Market Research Analyst

The cardiovascular market, particularly for heart failure and cardiogenic shock, is a high-need, high-value space. Windtree's exploration into SERCA2a activators positions the company in a market with an estimated value of $1.25 billion. The stark statistic that 99% of cardiologists acknowledge the necessity for new drug innovation underscores the critical demand for therapeutic advances. This demand, coupled with the significant mortality rates associated with cardiogenic shock, indicates a substantial market opportunity for effective treatments.

Windtree's strategic collaboration and the anticipated results from the Phase 2 SEISMiC Extension Study in early cardiogenic shock could potentially lead to a breakthrough in a market where current pharmacological interventions are limited and often viewed as last-resort options due to their side effects. The company's progress in this area will likely be closely monitored by investors and healthcare professionals alike, as a successful outcome could lead to considerable market share and improved patient outcomes.

Financial Analyst

The partnership and ongoing research into SERCA2a activators can be seen as an investment into Windtree's pipeline, potentially enhancing its long-term valuation. The focus on a novel mechanism of action and the move towards oral administration for chronic heart failure treatment could differentiate Windtree from competitors and create a unique selling proposition. However, investors should be aware of the inherent risks associated with drug development, especially in the preclinical stage, where many compounds fail to advance to clinical trials or show efficacy in humans.

Furthermore, the expected mid-2024 results from the Phase 2 SEISMiC Extension Study will be a critical milestone for the company. Positive outcomes may lead to increased investor confidence and potentially drive up the stock price, while negative results could have the opposite effect. It is essential for investors to consider the long development timelines, regulatory hurdles and the capital required to bring these compounds to market when assessing Windtree's financial health and future prospects.

WARRINGTON, Pa., Feb. 01, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for critical cardiovascular disorders, today announced that it has renewed its partnership with Chang Gung University in Taiwan to further research on SERCA2a, an important target for the Company’s cardiovascular portfolio. Windtree personnel from its offices in Taipei, Taiwan will participate in the collaboration.

The scientific collaboration includes the Company’s lead product candidate istaroxime and the next generation compounds called SERCA2a activators. One of istaroxime’s mechanisms of action is facilitation of myocardial relaxation through activation of the SERCA2a calcium pump on the sarcoplasmic reticulum enhancing calcium reuptake from the cytoplasm. SERCA2a activity is decreased in heart failure and disordered calcium handling can play a role in cardiac arrythmias. Windtree believes activation of SERCA2a could represent an important advancement in heart failure treatment for patients. The SERCA2a activators are in the preclinical stage of development and have potential for intravenous administration or oral (tablet) use in the out-patient setting in chronic heart failure.

“We are pleased to utilize this scientific collaboration to further support the characterization of the potential benefits of SERCA2a activation in cardiovascular disease and support the advancement of the next generation assets in our portfolio,” said Craig Fraser, Windtree's President and Chief Executive Officer. “This collaboration recently provided preclinical data showing reduction in ischemia-reperfusion induced arrythmias with istaroxime and a pure SERCA2a activator compound.”

Arrythmias are irregular heartbeats that can impact the pumping function of the heart. Patients with heart failure and cardiomyopathy are at risk for arrythmias. Arrythmias in these patients can be caused by their underlying cardiac disease or by drugs used to treat the heart failure such as catecholamines. Arrythmias can impair proper filling of the heart with blood and, importantly, cardiac output to the body. Ventricular arrythmias are particularly dangerous and can be fatal.

Outside of this scientific collaboration, istaroxime is being studied in the Phase 2 SEISMiC Extension Study in early cardiogenic shock. Study results are expected in mid-2024. Cardiogenic shock is a serious condition that occurs when the heart is failing significantly and cannot pump enough blood and oxygen to the brain, kidneys, and other vital organs. Mortality rates are significant and, depending on severity, range from 7% to 40% in the U.S. There is a lack of satisfactory pharmacological intervention to reverse the condition as available therapies have unwanted side effects such as risk for arrhythmias, decreasing blood pressure, renal dysfunction and even increases in mortality that limit their usefulness and position them as “rescue medicines” for severe cases. Market research revealed 99% of 100 U.S.-based clinical cardiologists interviewed who treat cardiogenic shock patients responded that new drug innovation to treat these patients is highly needed. The cardiogenic shock worldwide total market value is estimated to be $1.25 billion, calculated by using cardiogenic shock patient U.S. hospital claims and worldwide prevalence data multiplied by assumed various regional prices of drug treatment.

About Istaroxime
Istaroxime is a first-in-class dual-mechanism therapy designed to improve both systolic and diastolic cardiac function. Istaroxime is a positive inotropic agent that increases myocardial contractility through inhibition of Na+/K+- ATPase with a complimentary mechanism that facilitates myocardial relaxation through activation of the SERCA2a calcium pump on the sarcoplasmic reticulum enhancing calcium reuptake from the cytoplasm. Data from multiple Phase 2 studies in patients with early cardiogenic shock or acute decompensated heart failure demonstrate that istaroxime infused intravenously significantly improves cardiac function and blood pressure without increasing heart rate or the incidence of cardiac rhythm disturbances.

About Pure SERCA2a Activators
These compounds activate SERCA2a and Windtree Therapeutics' research and development program is evaluating these preclinical product candidates, including oral and intravenous SERCA2a activator heart failure compounds.

About Windtree Therapeutics, Inc.
Windtree Therapeutics, Inc. is advancing late-stage interventions for cardiovascular disorders to treat patients in moments of crisis. Using new scientific and clinical approaches, Windtree is developing a multi-asset franchise anchored around compounds with an ability to activate SERCA2a, with lead candidate, istaroxime, being developed as a first-in-class treatment for cardiogenic shock and acute decompensated heart failure. Windtree’s heart failure platform includes follow-on pre-clinical SERCA2a activator assets as well. In pulmonary care, Windtree has focused on facilitating the transfer of the KL4 surfactant platform, to its licensee, Lee’s Pharmaceutical (HK) Ltd. and Zhaoke Pharmaceutical (Hefei) Co. Ltd. Included in Windtree’s portfolio is rostafuroxin, a novel precision drug product targeting hypertensive patients with certain genetic profiles.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The Company may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are based on information available to the Company as of the date of this press release and are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. Examples of such risks and uncertainties include: risks and uncertainties associated with the success and advancement of the clinical development programs for istaroxime and the Company’s other product candidates; the Company’s ability to secure significant additional capital as and when needed; the Company’s ability to access the debt or equity markets; the Company’s ability to manage costs and execute on its operational and budget plans; the results, cost and timing of the Company’s clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; risks related to technology transfers to contract manufacturers and manufacturing development activities; delays encountered by the Company, contract manufacturers or suppliers in manufacturing drug products, drug substances, and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including that: (i) the U.S. Food and Drug Administration or other regulatory authorities may not agree with the Company on matters raised during regulatory reviews, may require significant additional activities, or may not accept or may withhold or delay consideration of applications, or may not approve or may limit approval of the Company’s product candidates, and (ii) changes in the national or international political and regulatory environment may make it more difficult to gain regulatory approvals and risks related to the Company’s efforts to maintain and protect the patents and licenses related to its product candidates; risks that the Company may never realize the value of its intangible assets and have to incur future impairment charges; risks related to the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the Company’s product candidates, if approved; the economic and social consequences of the COVID-19 pandemic and the impacts of political unrest, including as a result of geopolitical tension, including the conflict between Russia and Ukraine, the People’s Republic of China and the Republic of China (Taiwan), and the evolving events in Israel and Gaza, and any sanctions, export controls or other restrictive actions that may be imposed by the United States and/or other countries which could have an adverse impact on the Company’s operations, including through disruption in supply chain or access to potential international clinical trial sites, and through disruption, instability and volatility in the global markets, which could have an adverse impact on the Company’s ability to access the capital markets. These and other risks are described in the Company’s periodic reports, including its Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Contact Information:
Eric Curtis
ecurtis@windtreetx.com

What is Windtree Therapeutics, Inc.'s ticker symbol?

Windtree Therapeutics, Inc.'s ticker symbol is WINT.

What is the focus of Windtree Therapeutics, Inc.'s scientific collaboration with Chang Gung University in Taiwan?

The focus of the scientific collaboration is to further research on SERCA2a, an important target for the Company’s cardiovascular portfolio.

What is the Phase 2 SEISMiC Extension Study studying?

The Phase 2 SEISMiC Extension Study is studying istaroxime in early cardiogenic shock.

What is the estimated worldwide total market value for cardiogenic shock treatment?

The estimated worldwide total market value for cardiogenic shock treatment is $1.25 billion.