Exalenz Bioscience has partnered with Galectin Therapeutics to use its BreathID test to monitor patients in a Phase II study assessing GR-MD-02, which is an investigational treatment for patients with cirrhosis associated with nonalcoholic steatohepatitis (NASH Cirrhosis).
The 156 patient, multicenter, randomized, placebo-controlled and double-blind clinical study will assess the safety and efficacy of GR-MD-O2 to treat liver fibrosis and portal hypertension in patients with NASH Cirrhosis.
Under the study, Exalenz will assess 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 obtained investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for the study.
In the trial, the enrolled participants will receive three breath-based tests, where the first will be given during the screening stage, second at week 25 of treatment and third after the final dose of GR-MD-02.
The study results will be used to further assess the efficacy of BreathID and to optimize the firm’s proprietary algorithm to monitor the progression of NASH Cirrhosis to determine the clinical effectiveness of Galectin’s GR-MD-02 treatment among enrolled patients.
According to of Exalenz, the trial is part of the firm’s growing clinical pipeline of investigational diagnostic applications utilizing BreathID to diagnose for serious liver diseases.