Exalenz and Galectin collaborate in clinical trial of GR-MD-02 for NASH

Exalenz Bioscience announced it will collaborate with Galectin Therapeutics Inc. and use their noninvasive product, the BreathID test, for Galectin’s phase 2 clinical trial that will be investigating GR-MD-02 for the treatment of patients with nonalcoholic steatohepatitis with cirrhosis, according to a press release.

The study, also known as the NASH-CX trial, is a randomized, parallel group trial that will investigate the safety and efficacy of GR-MD-02 (Galectin Therapeutics), a complex carbohydrate drug that targets galectin-3, for the treatment of liver fibrosis and resultant portal hypertension in patients with NASH.

The trial will include a total of 156 patients from up to 60 clinical sites that will receive either 2 mg/kg of GR-MD-02, 8 mg/kg of GR-MD-02 or placebo. Fifty two patients will be in each group and receive a total of 26 infusions every other week for 1 year and will be evaluated to determine the change in hepatic venous pressure gradient (HVPG) in patients dosed with GR-MD-02 compared with patients dosed with placebo. Among these patients, each will receive three breath-based tests during the study: the first during the screening stage, second at 25 weeks of treatment and the third after the final dose of GR-MD-02. Exalenz will investigate the clinical utility of BreathID to follow up the effect of treatment on patients with NASH cirrhosis and then compare them with standard medical tests including HVPG, liver biopsy results and liver stiffness testing, according to the release.

“It has been reported that NASH affects up to 10 percent of the U.S. population and represents a significant unmet medical need with no currently approved pharmacological treatment,” Raffi Werner, CEO of Exalenz Bioscience, said in the release. “Currently, the only valid measures for diagnosis and follow up are invasive liver biopsy and HVPG. We are excited to collaborate with Galectin Therapeutics in this clinical study and believe that our noninvasive, operator-independent, breath-based test has the potential to assist clinicians in determining patient suitability for treatment and to conveniently and cost-effectively monitor the effect of therapy at the point of care.”

“Early clinical data evaluating GR-MD-02 have been encouraging, demonstrating that our potential treatment for NASH cirrhosis is safe, well-tolerated and achieved the targeted therapeutic dose,” Peter G. Traber, MD, president, CEO and chief medical officer of Galectin, said in the release. “We are excited to be initiating a larger study in a broader patient population, and proud to be partnering with Exalenz Bioscience to further validate how their novel, noninvasive, breath-based technology can be used to select patients with NASH cirrhosis who are candidates for therapy and to follow up the effect of our drug. The data from the BreathID will provide valuable information for clinical stage pharmaceutical companies actively working on bringing new therapeutic options to patients.”

Disclosures: Werner reports being employed by Exalenz. Traber reports being employed by Galectin.