Galectin settles plans for phase 3 trial of NASH-cirrhosis therapy

Galectin Therapeutics announced plans for a phase 3 clinical trial of belapectin for patients with nonalcoholic steatohepatitis-related cirrhosis without esophageal varices, according to a press release.

“We are undertaking an adaptively designed trial that begins by confirming dose selection and the results observed in the NASH-CX trial,” Harold H. Shlevin, PhD, president and CEO of Galectin, said in the release. “An interim assessment of efficacy of belapectin, selection of an optimal dose and sizing will be conducted on an initial group of patients after 12 to 18 months of treatment, to seamlessly inform the progression to an integrated phase 3 portion of trial.”

Shlevin also noted that the company will conduct a hepatic impairment study in parallel to “allow potential inclusion of patients with advanced cirrhosis in the trial,” he said.

Belapectin, also known as GR-MD-02, is a complex carbohydrate drug that targets and disrupts galectin-3, a critical protein in the pathogenesis of fatty liver disease and fibrosis.

The target population of the NASH-RX phase 3 trial is patients with NASH-related cirrhosis with clinical signals suggesting portal hypertension who are at risk for esophageal varices.

Galectin anticipates first patient enrollment to begin at the end of the first quarter of 2020.

Reference: www.galectintherapeutics.com