Galectin Therapeutics to Release Data from Phase 2b/3 NAVIGATE Study in Q4 2024

March 21, 2024 | by


Galectin Therapeutics, a biotechnology company specializing in the development of therapeutics for fibrotic and inflammatory diseases, is set to release data from its phase 2b/3 NAVIGATE study in the fourth quarter of 2024. The study aims to investigate the potential of Belapectin in preventing esophageal varices in patients with non-alcoholic steatohepatitis (NASH) cirrhosis. Belapectin has already demonstrated effectiveness in treating patients without esophageal varices in a previous study. With the global NASH market projected to reach $14.53 billion by 2028, the release of this data holds significant implications for Galectin Therapeutics’ future prospects. Moreover, the company is also exploring the use of Belapectin in combination with Keytruda for the treatment of advanced head and neck squamous cell carcinoma. However, it is important to consider potential risks such as the success of the NAVIGATE study, securing financing for the Keytruda combination study, and the company’s financial position, which may necessitate raising funds before the end of 2024.

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Galectin Therapeutics to Release Data from Phase 2b/3 NAVIGATE Study in Q4 2024

Galectin Therapeutics

Galectin Therapeutics, a biopharmaceutical company, focuses on the development and commercialization of therapies for fibrotic diseases and cancer. With a commitment to addressing unmet medical needs, Galectin Therapeutics strives to improve patient outcomes and quality of life. The company has gained recognition in the pharmaceutical industry for its innovative research and development efforts in the field of galectin receptors.

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Phase 2b/3 NAVIGATE Study

Overview of the NAVIGATE Study

The Phase 2b/3 NAVIGATE study is a pivotal clinical trial being conducted by Galectin Therapeutics. The study aims to investigate the potential use of Belapectin for the prevention of esophageal varices in patients with NASH Cirrhosis. Esophageal varices are enlarged veins in the esophagus that can be a serious complication of liver cirrhosis. By exploring the efficacy of Belapectin in preventing the development of esophageal varices, Galectin Therapeutics hopes to provide a novel and promising therapeutic option for patients.

Aims and Objectives of the NAVIGATE Study

The primary objective of the NAVIGATE study is to evaluate the efficacy and safety of Belapectin in reducing the risk of esophageal varices in NASH Cirrhosis patients. The study seeks to establish whether Belapectin can effectively inhibit fibrogenesis, the formation of excessive fibrous tissue in the liver, thereby reducing the likelihood of esophageal varices. Secondary objectives include assessing the impact of Belapectin on liver function, overall survival, and quality of life.

Patient Population and Inclusion Criteria

The NAVIGATE study focuses on patients diagnosed with NASH Cirrhosis, a form of liver cirrhosis associated with non-alcoholic steatohepatitis (NASH). Patients eligible for enrollment in the study must meet specific inclusion criteria, such as having a confirmed diagnosis of NASH and evidence of liver cirrhosis. Furthermore, patients must be free from esophageal varices at the time of enrollment to ensure a controlled study population.

Study Design and Protocol

The NAVIGATE study utilizes a randomized, double-blind, placebo-controlled design to investigate the efficacy and safety of Belapectin. Patients will be randomly assigned to receive either Belapectin or a placebo, and neither the patients nor the investigators will know which treatment they are receiving. The study will monitor patients over an extended period to determine if Belapectin can prevent the development of esophageal varices. Robust data analysis and statistical methods will be employed to assess the outcomes and draw meaningful conclusions.

Expected Data Release in Q4 2024

Galectin Therapeutics has projected that data from the NAVIGATE study will be released in the fourth quarter of 2024. This anticipated timeline will allow for thorough analysis of the study’s outcomes and provide valuable insights into the potential of Belapectin as a preventive treatment for esophageal varices in NASH Cirrhosis patients. The data release is highly anticipated by the medical community and investors alike, as the findings have the potential to shape future treatment strategies in this area.

Belapectin for Prevention of Esophageal Varices

Explanation of Esophageal Varices

Esophageal varices are abnormal, enlarged veins that develop in the lower part of the esophagus as a consequence of liver cirrhosis. Cirrhosis is a condition characterized by the irreversible scarring of the liver tissue, often caused by chronic liver diseases such as NASH. Esophageal varices can pose a significant risk of bleeding, and if left untreated, this complication can be life-threatening. Preventive measures to reduce the development and progression of esophageal varices are of paramount importance in the management of liver cirrhosis.


Previous Study on Belapectin

In a previous study, Belapectin demonstrated promising efficacy in treating patients without esophageal varices. The study evaluated the effects of Belapectin on liver fibrosis in patients with NASH Cirrhosis. Results indicated that Belapectin was able to significantly reduce liver fibrosis, suggesting its potential as an anti-fibrotic therapy. These positive findings provide a strong basis for investigating the use of Belapectin as a preventive treatment for esophageal varices.

Effectiveness of Belapectin Without Esophageal Varices

Although the primary focus of the NAVIGATE study is the prevention of esophageal varices, the potential effectiveness of Belapectin in patients without existing varices should not be overlooked. By reducing liver fibrosis, Belapectin may offer additional benefits in terms of improving liver function, slowing disease progression, and enhancing patients’ overall quality of life. This comprehensive approach to managing NASH Cirrhosis exhibits the potential of Belapectin to address multiple aspects of the disease, providing a holistic treatment option for patients.

NASH Cirrhosis and Non-Alcoholic Steatohepatitis Market

Understanding NASH Cirrhosis

NASH Cirrhosis refers to the occurrence of liver cirrhosis in the context of non-alcoholic steatohepatitis (NASH), a condition characterized by the accumulation of fat in the liver. NASH is commonly associated with metabolic disorders such as obesity and diabetes. Over time, the accumulation of fat leads to inflammation and scarring, ultimately resulting in liver cirrhosis. NASH Cirrhosis represents a significant medical burden and calls for effective therapeutic interventions to improve patient outcomes.

Current Market Size of Non-Alcoholic Steatohepatitis

The global non-alcoholic steatohepatitis market is witnessing significant growth, driven by the rising prevalence of NASH and the increasing awareness of its impact on public health. According to recent market reports, the market size for non-alcoholic steatohepatitis was valued at $XX billion in 2020. Factors contributing to market growth include the growing demand for effective treatment options and the introduction of innovative therapies. With an expanding patient population, the market presents substantial opportunities for Galectin Therapeutics and its investigational treatments.

Projected Growth of the Market by 2028

Market projections indicate that the non-alcoholic steatohepatitis market is poised for continued growth in the coming years. By 2028, the market is projected to reach a value of $14.53 billion, reflecting a compound annual growth rate of XX%. This projected growth is attributed to factors such as the increasing prevalence of NASH, the growing awareness of its long-term consequences, and the intensified research and development efforts aimed at finding effective therapeutic solutions. Galectin Therapeutics, with its ongoing studies and innovative therapies, is well-positioned to contribute to the expansion of this market.

Investigation of Belapectin and Keytruda Combination

Explanation of Keytruda

Keytruda is a well-known immunotherapy drug that targets programmed cell death protein 1 (PD-1). PD-1 is a protein receptor found on certain immune cells that functions to dampen immune responses, preventing them from attacking healthy cells. By inhibiting PD-1, Keytruda enhances the immune system’s ability to recognize and destroy cancer cells. Keytruda has demonstrated significant efficacy in various cancer types, making it a promising candidate for combination therapies.

Use of Belapectin and Keytruda Combination

Galectin Therapeutics is investigating the potential of combining Belapectin with Keytruda in the treatment of advanced head and neck squamous cell carcinoma (HNSCC). By combining these two therapeutic approaches, Galectin Therapeutics aims to enhance the anti-cancer effects of Keytruda while leveraging the anti-fibrotic properties of Belapectin. This combination approach holds promise for improved treatment outcomes and may offer new possibilities for patients with HNSCC.

Treatment of Advanced Head and Neck Squamous Cell Carcinoma

Advanced head and neck squamous cell carcinoma represents a significant challenge in oncology due to its aggressive nature and limited treatment options. Immunotherapy has emerged as a potential breakthrough in the management of this disease, with Keytruda being at the forefront of innovation. By combining Keytruda with Belapectin, Galectin Therapeutics seeks to capitalize on the immunotherapeutic benefits of Keytruda while targeting the fibrotic aspects associated with HNSCC. This synergy holds the potential to revolutionize the treatment landscape for patients with advanced HNSCC.

Financial Considerations for Galectin Therapeutics

Potential Need for Fundraising

With the ambitious research and development efforts underway at Galectin Therapeutics, the company may face a potential need for fundraising in the future. Conducting clinical trials, such as the NAVIGATE study and the Belapectin and Keytruda combination study, requires substantial financial resources. Securing funding through avenues such as partnerships, grants, or equity offerings will be crucial for Galectin Therapeutics to progress its pipeline and maintain its innovative approach to therapeutics.

Factors Affecting Financing for Keytruda Combination Study

The financing landscape for the Belapectin and Keytruda combination study may be influenced by several factors. Key considerations include the perceived potential of the combination therapy in the treatment of HNSCC, the competitive landscape of the oncology market, and the willingness of investors to support innovative therapies. Galectin Therapeutics will need to effectively communicate the scientific rationale, demonstrate the synergistic benefits of the combination, and showcase its commitment to improving patient outcomes to secure the necessary financial resources.

Evaluation of Galectin Therapeutics’ Current Financial Position

To navigate the challenges and potential fundraising requirements, a comprehensive evaluation of Galectin Therapeutics’ current financial position is essential. Factors such as available cash reserves, ongoing revenue streams, and financial projections need to be carefully assessed. By conducting a thorough analysis, Galectin Therapeutics can proactively address any financial gaps and make strategic decisions to ensure the successful execution of its clinical trials and future growth.

Risks and Challenges

Success and Implications of the NAVIGATE Study

The success of the NAVIGATE study and the implications of its results are critical to Galectin Therapeutics’ future prospects. While the study holds promise, there is always an inherent risk that the data may not meet the desired endpoints or demonstrate the expected efficacy and safety profile of Belapectin. Unfavorable outcomes could impact the company’s ability to attract further investment, affect its reputation in the pharmaceutical industry, and hinder its ability to advance therapeutic options for patients with NASH Cirrhosis.

Financing Challenges for Keytruda Combination Study

Securing adequate financing for the Belapectin and Keytruda combination study poses a significant challenge for Galectin Therapeutics. The costs associated with conducting rigorous clinical trials, especially in oncology, can be substantial. Galectin Therapeutics must navigate potential obstacles in obtaining funding to ensure the timely execution of the combination study. Failure to secure sufficient financial resources may delay or even jeopardize the progress of this innovative research endeavor.

Assessment of Galectin Therapeutics’ Financial Stability

A comprehensive assessment of Galectin Therapeutics’ financial stability is necessary to address potential risks and challenges. Factors such as adequate cash flow, investor confidence, and effective financial management play crucial roles in ensuring the company’s long-term viability. By continually monitoring and optimizing its financial position, Galectin Therapeutics can mitigate risks, navigate challenges, and foster a solid foundation for its ongoing studies and future growth.

In conclusion, Galectin Therapeutics is a prominent player in the biopharmaceutical industry, focusing on developing innovative therapies for fibrotic diseases and cancer. The Phase 2b/3 NAVIGATE study explores the use of Belapectin for preventing esophageal varices in NASH Cirrhosis patients, while the investigation of the Belapectin and Keytruda combination shows promise in advanced HNSCC. Galectin Therapeutics must address potential financial considerations and navigate risks to realize its mission of improving patient outcomes and making substantial contributions to the pharmaceutical industry.

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