Galectin Plans to Present Data from Phase 2 NASH Cirrhosis Trial by Year’s End

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by Alice Melao |

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GR-MD-02 for NASH cirrhosis

Galectin Therapeutics’s lead drug GR-MD-02 may be a promising therapeutic approach to treat fibrosis in fatty liver disease — or non-alcoholic steatohepatitis (NASH) — based on results from a Phase 1 study. The company is currently conducting a Phase 2 trial for this disease and expects to have initial results in December 2017.

Galectin, based in Norcross, Georgia, is a biotech focused on the development of new therapies to improve the lives of patients with cancer and chronic liver and skin diseases.

The company’s lead drug is a carbohydrate-based inhibitor that targets galectin-3, or Gal-3.

Galectins are proteins produced by many cells but they can be found at higher levels in a subset of immune cells called macrophages. Gal-3 is one of the most prominent galectin proteins involved in several disease-associated mechanisms, such as faulty immune cells, inflammatory and fibrotic process, and malignant transformation.

With no approved therapies, NASH with fibrosis, or in more severe cases cirrhosis, remains an unmet medical need. Development of a drug that could block fibrosis progression or reverse it for treatment of NASH cirrhosis patients would be an important breakthrough, preventing clinical complications and the need for liver transplants.

Previous results from preclinical studies and a Phase 1 clinical trial (NCT01899859) showed that GR-MD-02 can be a powerful drug with therapeutic effects in NASH patients with advanced fibrosis and cirrhosis. These results supported the initiation of Phase 2 clinical trials to further determine the drug’s safety and effectiveness.

“Galectin Therapeutics achieved a number of significant milestones in the development of our lead compound, GR-MD-02, during 2016,” Peter G. Traber, president, CEO, and chief medical officer of Galectin Therapeutics, said in a company press release.

The ongoing Galectin’s Phase 2b NASH-CX trial (NCT02462967) was designed to determine the safety and effectiveness of GR-MD-02 vs. placebo for the treatment of liver fibrosis, and resultant high blood pressure in the liver, in patients with NASH cirrhosis.

The trial has exceeded the company’s expectations in participant enrollment. To date, 71 people have completed the treatment, and 155 patients are still under treatment, with no serious treatment-associated adverse events reported. More results are expected at the end of 2017.