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Data Collected by Exalenz Bioscience in Galectin Therapeutics' Phase 2 NASH-CX Trial of GR-MD-02 to Be Presented at AASLD Annual Meeting
Globe Newswire 5-Nov-2018 8:15 AM
NORCROSS, Ga., Nov. 05, 2018 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, today announced that an abstract based on results obtained in Galectin Therapeutics' NASH-CX Phase 2 Clinical Trial has been accepted for a poster presentation by Exalenz Bioscience at The Liver Meeting, the annual meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco on November 9-13, 2018. The poster presentation is titled "The noninvasive point of care MBT accurately predicts decompensation events better than MELD in compensated (MELD<15) NASH cirrhotics" authored by Naga Chalasani, et al. The poster illustrates Exalenz Bioscience's 13C-Methacetin Breath Test's (MBT) ability to predict decompensation in compensated NASH cirrhotics. MBT was performed on 160 patients with compensated NASH cirrhosis (i.e. no prior variceal hemorrhage, ascites or hepatic encephalopathy) in Galectin Therapeutics' NASH-CX Phase 2 Clinical Trial. All were followed prospectively for decompensation.
The study showed that MBT, which measures liver function, strongly predicts liver decompensation in patients with compensated NASH cirrhosis. The data suggest that this non-invasive, valid, operator-independent, point-of-care tool is safe and may be a more effective clinical tool than instruments currently used to help identify patients at increased risk for hepatic decompensation.
The poster itself will be released in accordance with AASLD's policies.
Saturday, November 10, 2018 at 2:00 p.m. PST Poster Session II Moscone Center, Hall C "The noninvasive point of care MBT accurately predicts decompensation events better than MELD in compensated (MELD<15) NASH cirrhotics." N. Chalasani, et al. Abstract #1337
About NASH-CX Phase 2b Trial
Galectin Therapeutics announced top-line results from its NASH-CX Phase 2 trial in December 2017. The Company is proceeding with plans for a Phase 3 clinical trial program with its galectin-3 inhibitor GR-MD-02 in NASH cirrhosis, incorporating advice and guidance obtained in a meeting with the FDA. Details of the Phase 3 clinical trial design, including projected timings and costs, will be announced once the planning phase has been completed and the Company has submitted a final clinical trial protocol with the FDA.
About Galectin Therapeutics
Galectin Therapeutics is dedicated to developing novel therapies to improve the lives of patients with chronic liver disease and cancer. Galectin's lead drug (GR-MD-02) is a carbohydrate-based drug that inhibits the galectin-3 protein which is directly involved in multiple inflammatory, fibrotic, and malignant diseases. The lead development program is in non-alcoholic steatohepatitis (NASH) with cirrhosis, the most advanced form of NASH related fibrosis. This is the most common liver disease and one of the largest drug development opportunities available today. Additional development programs are in treatment of severe atopic dermatitis, moderate-to-severe plaque psoriasis, and in combination immunotherapy for advanced melanoma and other malignancies; advancement of these additional clinical programs is largely dependent on finding a suitable partner. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient development. Additional information is available at www.galectintherapeutics.com.
About Exalenz Bioscience Exalenz Bioscience develops and markets diagnostic tests and monitoring systems that use the breath to diagnose and help manage gastrointestinal and liver conditions. The company's flagship BreathID® Hp offers the most efficient and accurate test for detection of H. pylori bacteria, associated with various illnesses including gastric cancer, and is already in use in over 400 U.S. medical centers and major labs across the country. The BreathID 13C-methacetin breath test (MBT) is a sensitive, noninvasive, point of care tool that measures the microsomal function of the liver. Exalenz holds regulatory approvals in Europe, the United States, China and Israel for H. pylori detection and is currently evaluating additional applications of the BreathID platform, including MBT in the detection of CSPH in patients with NASH. Additional information is available at www.exalenz.com.
