Galectin begins enrollment for phase 2 trial of NASH drug

Galectin Therapeutics Inc. announced enrollment of patients for its phase 2 clinical trial that will investigate 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, according to the release.

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, according to the release. 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 in patients dosed with GR-MD-02 compared with patients dosed with placebo.

“We have worked diligently along with [Pharmaceutical Product Development, LLC], our contract research organization, to advance to this point in our development,” Peter G. Traber, MD, president, CEO and chief medical officer of Galectin, said in the release. “PPD has extensive experience in conducting clinical trials in NASH and cirrhosis, and we are very pleased with the pace of site recruitment. In addition, these sites have experience with measuring hepatic venous pressure gradient, our primary endpoint, which is reflective of clinical outcomes in cirrhosis.”

The trial is spearheaded by Stephen A. Harrison, MD, FACP, of the Brooke Army Medical Center/San Antonio Military Medical Center, and Naga Chalasani, MD, FACG, of Indiana University School of Medicine.

“The commercial potential of a drug that treats late stage fibrosis and cirrhosis should be excellent,” Traber said. “While many other companies are investigating therapeutics in early, low stage fibrosis NASH, we believe that the sense of urgency for treatment by physicians, patients and payers will be less robust than that of late stage NASH with its heightened mortality. In fact, the scope of this disease is such that by 2025 the worldwide market for NASH treatments could approach $35 billion, according to a recent biotech analyst report.”

Disclosures: Traber reports being employed by Galectin. Healio.com/Hepatology was unable to confirm relevant financial relationships of Harrison and Chalasani at the time of publication.