Exalenz Bioscience announced a collaboration with Galectin Therapeutics to use the BreathID test to monitor patients in a Phase II study evaluating GR-MD-02. GR-MD-02 is an investigational treatment for patients with cirrhosis associated with nonalcoholic steatohepatitis (NASH Cirrhosis). The 156 patient, multicenter, randomized, placebo-controlled, double-blind clinical trial will evaluate the safety and efficacy of GR-MD-O2 for the treatment of liver fibrosis and portal hypertension in patients with NASH Cirrhosis.

As part of the study, Exalenz will investigate the clinical utility of BreathID® to follow up the effect of treatment on patients with NASH Cirrhosis, compared to standard medical tests including hepatic venous pressure gradient (HVPG), liver biopsy results, and liver stiffness testing. Exalenz recently received approval from the U.S. Food and Drug Administration (FDA) of an investigational device exemption (IDE) for the trial. During the study, enrolled participants will receive three breath-based tests: the first will be given during the screening stage, the second will be given at week 25 of treatment and the third will be given after the final dose of GR-MD-02.

The results of this study will be used to further evaluate the efficacy of BreathID® and to optimize the company's proprietary algorithm for monitoring the progression of NASH Cirrhosis to determine the clinical effectiveness of Galectin Therapeutics' GR-MD-02 treatment among enrolled patients. Exalenz Bioscience expects that the optimized algorithm will continue to be applied to data collected in its other ongoing studies.