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Galectin Therapeutics, Inc. (NASDAQ: GALT) is a leading developer of compounds that target galectin proteins to treat fibrosis and cancer. It has been estimated that 45% of U.S. deaths are due to various types of fibrosis – heart, lung, kidney, liver. 1 Liver Fibrosis, Cirrhosis, and NASH Liver fibrosis, caused by fatty liver disease, is a hidden epidemic across the world, largely driven by increases in obesity and diabetes. As many as one in four people globally suffer from fatty liver disease, which can progress to NASH (non-alcoholic steatohepatitis) and NASH cirrhosis as the fibrosis increases, with a lifetime risk of ~20 million liver-related deaths among fatty liver disease patients currently alive. 2 Currently, the only treatment for patients with NASH cirrhosis is a liver transplant. The potential market opportunity for drugs targeting NASH and cirrhosis is projected to be $35 - $40B worldwide in 2025. 3 A key indicator for the prognosis for NASH cirrhosis patients is the development of esophageal varices, a widening of the veins in the esophagus and other areas caused by impeded blood flow and increased portal pressure due to liver cirrhosis. Results from Galectin Therapeutics’ Phase 2b NASH-CX Trial showed that its drug, GR-MD-02, demonstrated statistically significant and clinically meaningful results in reducing HVPG (hepatic venous pressure gradient) in NASH cirrhosis patients without esophageal varices. This was the first randomized clinical trial of any drug to demonstrate statistically significant positive efficacy in compensated NASH cirrhosis without varices, and the drug was safe and well tolerated. This subgroup is large and commercially relevant as it comprises about half of all patients with NASH cirrhosis. GR-MD-02 also demonstrated a statistically significant improvement in portal pressure, an improvement in liver cell death (hepatocyte ballooning), and a reduction in the development of new esophageal varices at the end of the one-year study. After incorporating advice and guidance from the U.S. Food and Drug Administration (FDA), Galectin Therapeutics is proceeding with plans for a Phase 3 clinical trial program for GR-MD-02 in NASH cirrhosis. Current Pipeline 1 Wynn, TA. Nat Rev Immunol. 2004;4:583–594. doi:10.1038/nri1412 2 Rinella M, Charlton M. The globalization of nonalcoholic fatty liver disease: Prevalence and impact on world health. Hepatology 2016 Jul;64(1):19-22 3 Who will be the kings of NASH-ville? Key players and an overview. May 21, 2015, Alethia Young, Deutsche Bank Markets Research Galectin Therapeutics 4960 Peachtree Industrial Blvd, Suite 240 Norcross, GA 30071 (678) 620-3186 www.galectintherapeutics.com Media contact: [email protected], 610-228-2108

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  • Galectin Therapeutics, Inc. (NASDAQ: GALT) is a leading developer of compounds that target galectin proteins to treat fibrosis and cancer. It has been estimated that 45% of U.S. deaths are due to various types of fibrosis – heart, lung, kidney, liver.1

    Liver Fibrosis, Cirrhosis, and NASH Liver fibrosis, caused by fatty liver disease, is a hidden epidemic across the world, largely driven by increases in obesity and diabetes. As many as one in four people globally su�er from fatty liver disease, which can progress to NASH (non-alcoholic steatohepatitis) and NASH cirrhosis as the fibrosis increases, with a lifetime risk of ~20 million liver-related deaths among fatty liver disease patients currently alive.2

    Currently, the only treatment for patients with NASH cirrhosis is a liver transplant. The potential market opportunity for drugs targeting NASH and cirrhosis is projected to be $35 - $40B worldwide in 2025.3

    A key indicator for the prognosis for NASH cirrhosis patients is the development of esophageal varices, a widening of the veins in the esophagus and other areas caused by impeded blood flow and increased portal pressure due to liver cirrhosis.

    Results from Galectin Therapeutics’ Phase 2b NASH-CX Trial showed that its drug, GR-MD-02, demonstrated statistically significant and clinically meaningful results in reducing HVPG (hepatic venous pressure gradient) in NASH cirrhosis patients without esophageal varices. This was the first randomized clinical trial of any drug to demonstrate statistically significant positive e�cacy in compensated NASH cirrhosis without varices, and the drug was safe and well tolerated. This subgroup is large and commercially relevant as it comprises about half of all patients with NASH cirrhosis.

    GR-MD-02 also demonstrated a statistically significant improvement in portal pressure, an improvement in liver cell death (hepatocyte ballooning), and a reduction in the development of new esophageal varices at the end of the one-year study. After incorporating advice and guidance from the U.S. Food and Drug Administration (FDA), Galectin Therapeutics is proceeding with plans for a Phase 3 clinical trial program for GR-MD-02 in NASH cirrhosis.

    Current Pipeline

    1 Wynn, TA. Nat Rev Immunol. 2004;4:583–594. doi:10.1038/nri14122 Rinella M, Charlton M. The globalization of nonalcoholic fatty liver disease: Prevalence and impact on world health. Hepatology 2016 Jul;64(1):19-223 Who will be the kings of NASH-ville? Key players and an overview. May 21, 2015, Alethia Young, Deutsche Bank Markets Research

    Galectin Therapeutics4960 Peachtree Industrial Blvd, Suite 240

    Norcross, GA 30071(678) 620-3186

    www.galectintherapeutics.comMedia contact: [email protected], 610-228-2108

  • About Galectin Proteins and GR-MD-02 Galectins are proteins found most frequently in the immune system, though they are normally expressed in many di�erent cell types. An increase in galectin proteins is seen in a number of diseases, including inflammation, insulin-resistance, scarring of organs and many cancers. This increase in galectin proteins promotes the disease and is detrimental to the patient.

    GR-MD-02 is a complex carbohydrate drug that binds and inhibits galectin-3, a protein which plays a central role in inflammation, fibrogenesis and tumor formation. GR-MD-02 has demonstrated low toxicity potential, as carbohydrates are generally metabolized to simple sugars with limited toxicity, unlike some other drugs.

    Patent protection through at least 2031. GR-MD-02 is covered by a strong and robust IP portfolio of 46 granted and 50 pending patents across a broad group of human diseases through at least 2031.

    Other Indications Galectin proteins have shown clinical e�cacy in severe skin diseases. A Phase 2a, 24-week, open label exploratory trial in patients with severe plaque psoriasis demonstrated that all five patients treated showed improvement in disease activity by an average of 50%.

    In a separate, investigator-initiated study, a 36-year-old male with a 20-year history of severe atopic dermatitis is being treated with GR-MD-02 after failing approved standard-of-care therapies. Initial results have shown eczema area and severity index (EASI) improved 65% and severity scoring of atopic dermatitis index (SCORAD) improved 56%. Investigators continue to enroll patients. Galectin proteins also play a role in the immune response in cancer. Galectin Therapeutics is exploring GR-MD-02 in combination with immunotherapy in advanced melanoma and other malignancies. A Phase 1b trial with Keytruda® is underway and is being conducted by leading researchers at Providence Portland Medical Center. It is hoped that additional data will be reported in summer 2018 when the company anticipates a decision on progressing to Phase 2.

    Management Team The management team at Galectin Therapeutics has significant drug-development, commercialization and manufacturing experience in companies such as Solvay Pharmaceuticals, Abbott Laboratories, CIBA-Geigy Pharmaceuticals, Corautus Genetics, REACH Health, Vystar Corporation, and Chelsea Therapeutics. Harold Shlevin, Ph.D., CEO has nearly 25 years of senior management experience in the development and commercialization of pharmaceuticals, diagnostics, and vaccines at Georgia Institute of Technology’s Advanced Technology Development Center (ATDC), Solvay Pharmaceuticals, CIBA-Geigy Pharmaceuticals, Tikvah Therapeutics, and Altea Therapeutics Corporation. Galectin Therapeutics provides regular updates on its work and therapeutic area via a blog entitled Galectin Perspectives, found at http://perspectives.galectintherapeutics.com/.

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    This document about Galectin Therapeutic, Inc. may contain forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events and use words such as "may," "could," "expect" and others. These statements include those regarding the hope that Galectin's development program for GR-MD-02 will show that it can be an e�ective drug for the treatment of fibrosis or cirrhosis in the liver and other organs, cancer or psoriasis. For a discussion of additional factors impacting Galectin's business, see the Company's Annual Report on Form 10-K, 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.

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