13C-Methacetin Breath Test accurately assesses clinically significant portal hypertension in patients with NASH cirrhosis
NORCROSS, Ga. (April 17, 2017) – Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, and Exalenz Bioscience (TASE: EXEN), a leader in developing and marketing non-invasive medical devices for diagnosing and monitoring a range of gastrointestinal and liver diseases, today announced the presentation of a late-breaking abstract at The International Liver Congress™ 2017. The data demonstrates the effectiveness of the Exalenz 13C-Methacetin Breath Test (MBT) as a non-invasive test of liver function.
Baseline data was collected from patients screened for the NASH-CX Phase 2 clinical trial sponsored by Galectin Therapeutics Inc. The trial is for patients with non-alcoholic steatohepatitis (NASH) with cirrhosis. The analysis of the data determined that MBT non-invasively detects clinically significant portal hypertension with high sensitivity and specificity (CSPH, defined as HVPG ≥ 10 mmHg). This is the main predictor of decompensation in NASH cirrhosis. This non-invasive test may serve as a useful tool in the stratification of patients with compensated NASH cirrhosis at point-of-care. Top Line data from Galectin Therapeutics NASH-CX trial is expected in December, 2017.
“There is a critical need for a non-invasive test for diagnosing and following treatment of fatty liver disease, NASH, and cirrhosis,” said Peter Traber, M.D., President, Chief Executive Officer and Chief Medical Officer of Galectin Therapeutics, which sponsored the study. “Currently, the only broadly accepted ways to assess a patient’s condition is via a liver biopsy or HVPG, both invasive tests with potential side effects. It would be a major benefit for physicians and patients if there was a simple, noninvasive test that would enable us to diagnose and track the progression of disease without resorting to biopsy or other invasive means.”
The poster presentation is based on data collected during patient screening for a Phase 2B clinical trial of Galectin Therapeutics’ galectin- inhibitor, GR-MD-02, in patients with NASH cirrhosis. Patients underwent hepatic venous pressure gradient (HVPG) measurement, an invasive test to confirm the presence (or absence) of CSPH as well as a liver biopsy. The patients also underwent an MBT, a noninvasive test of liver function based on the metabolism of non-radioactive 13C isotope-labeled Methacetin in expired breath. Data showed that MBT accurately predicted the presence of CSPH.
The International Liver Congress 2017, to be held in Amsterdam, the Netherlands from 19 to 23 April 2017, is the premier international conference of Hepatologists held each year by the European Association for the Study of the Liver (EASL).
Below are the presentation details:
Session: Late breaker posters
Date: April 20, 2017
Time: 8:00 am to 6:00 pm
A pdf version of the late breaking poster will be posted on www.galectintherapeutics.com on Wednesday, April 20, 2017.
GR-MD-02 is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of fatty liver disease and fibrosis. Galectin-3 plays a major role in diseases that involve scarring of organs including fibrotic disorders of the liver, lung, kidney, heart and vascular system. The drug binds to galectin proteins and disrupts their function. Preclinical data in animals have shown that GR-MD-02 has robust treatment effects in reversing liver fibrosis and cirrhosis.
About Galectin Therapeutics
Galectin Therapeutics is developing promising carbohydrate-based therapies for the treatment of fibrotic liver disease, cancer, atopic dermatitis, psoriasis and other related fibrotic conditions, based on the Company’s unique understanding of galectin proteins, which are key mediators of biologic function. Galectin seeks to leverage extensive scientific and development expertise, as well as, established relationships with external sources to achieve cost-effective and efficient development. The Company is pursuing a development pathway to clinical enhancement and commercialization for its lead compounds in liver fibrosis and cancer. Additional information is available at
Exalenz Bioscience develops and markets diagnostic and monitoring systems that use the breath to diagnose and help manage gastrointestinal and liver conditions. The company’s flagship BreathID® Hp test detects the presence of the H. pylori bacteria, associated with various illnesses including gastric cancer and is in use in over 350 US medical centers. Exalenz holds regulatory approvals in Europe, the United States, China and Israel for H. pylori detection and is currently in the process of obtaining approvals for additional applications. Additional information is available at int.exalenz.com.