Galectin Therapeutics Reports the Positive Outcome of the Fifth Data and Safety Monitoring Board Meeting for NAVIGATE Phase 2b/3 Study of Belapectin in Patients with Cirrhotic Portal Hypertension Caused by Metabolic Dysfunction-Associated SteatoHepatitis
Galectin Therapeutics, Inc. (NASDAQ: GALT) receives fifth positive recommendation from DSMB to continue Phase 2b/3 NAVIGATE study of belapectin in MASH liver cirrhosis. Interim efficacy readout anticipated in Q4 2024.
The continuation of the NAVIGATE study for belapectin is a significant milestone in the treatment of Metabolic Dysfunction-Associated SteatoHepatitis (MASH) liver cirrhosis. The DSMB's fifth recommendation without modifications underscores the safety and tolerability of the drug, which is a critical aspect of any clinical trial. The focus on portal hypertension and its complications, such as esophageal varices, is noteworthy as these are key indicators of disease progression and patient prognosis.
From a research perspective, the adaptive design of this trial is innovative, allowing for modifications based on interim results. This could potentially accelerate the development process and bring treatments to market more efficiently. The implications for Galectin Therapeutics are substantial, as positive results could lead to increased investor confidence and possibly partnerships or funding opportunities. However, investors should be aware that the interim efficacy readout is not expected until Q4 2024, which means there is still significant time before any definitive conclusions can be drawn about the drug's market potential.
The announcement from Galectin Therapeutics regarding the DSMB's positive recommendation to continue the Phase 2b/3 study of belapectin could be seen as an indicator of the company's solid clinical development strategy. For investors, the emphasis on safety and tolerability is an encouraging sign, as these factors are important for regulatory approval and market acceptance. It's also important to note that the market for liver cirrhosis treatments is underserved, with limited breakthroughs in the past decades, which could mean a significant market opportunity for belapectin if successful.
However, it is essential to maintain a balanced view. While the news is positive, the actual impact on the company's financials will not be immediate. The stock market response may be muted until the interim efficacy results are released. Furthermore, the biotech sector is known for its volatility and results from clinical trials can be unpredictable. Investors should consider the inherent risks associated with clinical-stage biopharmaceutical companies and diversify their portfolios accordingly.
Examining the broader market implications, the ongoing NAVIGATE study places Galectin Therapeutics at the forefront of addressing an unmet medical need in MASH liver cirrhosis. The successful development of belapectin could disrupt the current treatment landscape and offer a competitive advantage. The drug's safety profile and innovative trial design could set a new standard in the industry, potentially influencing future clinical research methodologies.
The anticipation of interim efficacy results creates a timeline for potential market entry. If the results are positive, Galectin Therapeutics could see a significant increase in market valuation. However, it's important to monitor competitive developments, as other companies may also be pursuing similar indications. Market dynamics, such as pricing pressures and reimbursement challenges, will also play a role in the commercial success of belapectin, should it receive regulatory approval.
04/09/2024 - 08:00 AM
Data and Safety Monitoring Board (DSMB) recommends the continuation, without modifications, of the adaptive Phase 2b/3 NAVIGATE study of belapectin in metabolic dysfunction-associated steatohepatitis (MASH) liver cirrhosis Fifth positive recommendation further supports favorable tolerability and safety profile of belapectin Interim Phase 2b efficacy readout anticipated in Q4 2024 NORCROSS, Ga., April 09, 2024 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc.
The objective of this fifth DSMB meeting was to further review the emerging tolerance and safety profiles of belapectin. Based on its deliberation, which included an unblinded review of the data collected thus far, the DSMB concluded that NAVIGATE can continue as designed, without modifications.
The Phase 2b/3 NAVIGATE study is a global, seamless, adaptive, randomized, placebo-controlled, double-blind trial. This is the first study of its kind in cirrhotic patients with an innovative adaptive design and an innovative primary outcome of efficacy, the prevention of esophageal varices, a clinical marker of portal hypertension which is an essential mechanism underlying the relentless progression of the disease. The adaptive study includes two stages: The Phase 2b portion, or Stage 1, has been fully enrolled with 357 patients who have clinical signs of portal hypertension, no cirrhosis decompensations, and no esophageal varices. Portal hypertension is the consequence of the unrelenting inflammatory and fibrotic process occurring in the liver and dramatically increases the risk of developing esophageal varices, a potentially life-threatening complication of liver cirrhosis.
Enrolled patients have been randomized to receive every two weeks a blinded infusion of belapectin at 2 mg/kg/LBM or 4 mg/kg/LBM or placebo. An interim analysis of safety and efficacy will be conducted once the last patient randomized into Stage 1 has been followed up for 18 months, and has had a second esophago-gastric endoscopy to evaluate for the presence or absence of esophageal varices. The results of this stage 1 interim analysis will determine if the study progresses into the Phase 3 portion of the trial, or Stage 2 , and which of the pre-specified protocol adaptations are to be integrated into this second stage.
The Stage 1 interim analysis has three possible outcomes: stop NAVIGATE because of overwhelming efficacy or because of futility, or initiate NAVIGATE Stage 2 because there is a favorable conditional probability of success regarding the final analysis that will take place at the end of Stage 2 (Phase 3). In this third scenario, adaptations to be selected include the choice of the best dose of belapectin and the final number of new patients to be randomized for ensuring an adequate study power for the Final Analysis.
Dr. Pol Boudes, M.D., Chief Medical Officer of Galectin Therapeutics, said: “The fifth positive recommendation of the DSMB to continue the trial without any modification confirms that our NAVIGATE study remains on track for an interim readout by the end of the year. Moreover, the recommendation further strengthens our confidence that belapectin appears generally safe and well tolerated, which is of great importance given the patients in our trial suffer from several co-morbidities and are on multiple medications, which increases the overall risk of severe complications. This safety profile can tip the balance in favor of the drug’s risk-benefit ratio, an essential element to support any drug approval. The innovative design of the NAVIGATE trial is essential to bring new momentum to clinical development in cirrhosis, a field that has not seen enough medical breakthroughs over the past 50 years. I am convinced that we must change the way we do clinical research if we want to bring hope to our patients. Our adaptive design, as well as our clinical efficacy criteria, represent a new way to evaluate cirrhosis treatment and we hope, if we are successful, that this approach will be emulated. The next DSMB meeting, in addition to the evaluation of belapectin profile, will evaluate the results of the interim analysis and provides its recommendation to Galectin Therapeutics. We are excited to continue our journey to bring patients with liver cirrhosis a potentially efficacious and safe treatment.”
The topline results from the Interim analysis of the Phase 2b (Stage 1) portion of NAVIGATE is expected in the fourth quarter of 2024.
About Belapectin NAVIGATE Phase 2b/3 trial (NCT04365868 ) to evaluate the efficacy and safety of belapectin for the prevention of esophageal varices in MASH cirrhosis. Galectin-3 has a significant role in cancer, and the Company has supported a Phase 1b study in combined immunotherapy of belapectin and KEYTRUDA in advanced melanoma and in head and neck cancer. This trial provided a strong rationale for moving forward into a Company-sponsored Phase 2 development program, which the company is exploring.
About liver cirrhosis due to MASH and portal hypertension
About Galectin Therapeutics www.galectintherapeutics.com
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as “may,” “estimate,” “could,” “expect”, “look forward”, “believe”, “hope” and others. They are based on management’s current expectations and are subject to factors and uncertainties that could cause actual results to differ materially from those described in the statements. These statements include those regarding the hope that Galectin’s development program for belapectin will lead to the first therapy for the treatment of MASH, formerly known as NASH, with cirrhosis and those regarding the hope that our lead compounds will be successful in cancer immunotherapy and in other therapeutic indications. Factors that could cause actual performance to differ materially from those discussed in the forward-looking statements include, among others, that trial endpoints required by the FDA may not be achieved; Galectin may not be successful in developing effective treatments and/or obtaining the requisite approvals for the use of belapectin or any of its other drugs in development; the Company may not be successful in scaling up manufacturing and meeting requirements related to chemistry, manufacturing and control matters; the Company’s current clinical trial and any future clinical studies may not produce positive results in a timely fashion, if at all, and could require larger and longer trials, which would be time consuming and costly; plans regarding development, approval and marketing of any of Galectin’s drugs are subject to change at any time based on the changing needs of the Company as determined by management and regulatory agencies; regardless of the results of any of its development programs, Galectin may be unsuccessful in developing partnerships with other companies or raising additional capital that would allow it to further develop and/or fund any studies or trials. Galectin has incurred operating losses since inception, and its ability to successfully develop and market drugs may be impacted by its ability to manage costs and finance continuing operations. For a discussion of additional factors impacting Galectin’s business, see the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause its views to change, management disclaims any obligation to update forward-looking statements.
Company Contact:
Jack Callicutt, Chief Financial Officer
Investors Relations Contacts: kgardner@lifesciadvisors.com
Chris Calabreseccalabrese@lifesciadvisors.com
Galectin Therapeutics and its associated logo is a registered trademark of Galectin Therapeutics Inc. Belapectin is the USAN assigned name for Galectin Therapeutics’ galectin-3 inhibitor belapectin (GR-MD-02).
What is the Phase of the NAVIGATE study for belapectin in liver cirrhosis?
The NAVIGATE study is an adaptive Phase 2b/3 study of belapectin in patients with cirrhotic portal hypertension caused by Metabolic Dysfunction-Associated SteatoHepatitis (MASH).
What is the primary outcome of the NAVIGATE study?
The primary outcome of the NAVIGATE study is the prevention of esophageal varices, a clinical marker of portal hypertension.
When is the interim Phase 2b efficacy readout expected?
The interim Phase 2b efficacy readout for belapectin in the NAVIGATE study is anticipated in Q4 2024.
Who is the Chief Medical Officer of Galectin Therapeutics?
Dr. Pol Boudes, M.D., is the Chief Medical Officer of Galectin Therapeutics.
What are the possible outcomes of the Stage 1 interim analysis of the NAVIGATE study?
The Stage 1 interim analysis can lead to stopping the study due to overwhelming efficacy or futility, or initiating Stage 2 based on a favorable conditional probability of success.
