Galectin Therapeutics Submits Seamless Adaptively-Designed Phase 2b/3 NASH-RX Protocol in NASH Cirrhosis - Seite 2

The new trial design also minimizes invasive testing requirements, which we believe will enhance the enrollment and retention of patients. It also provides for a seamless transition of patients from the phase 2b component into the phase 3 stage, as well as provides for the potential addition of new patients. The trial design preserves the surrogate end-point concepts previously discussed with the FDA.

As previously communicated, this is a uniquely challenging time to start a new clinical trial, and we are doing everything in our direct control to prepare for the initiation of the study later this quarter; however, factors beyond our control, specifically related to the COVID-19 pandemic, may delay the trial’s initiation.  Notwithstanding that, we remain optimistic in moving forward.  The unmet medical need for effective treatment for patients with NASH cirrhosis remains an important motivation.

The trial, entitled “A Seamless Adaptive Phase 2b/3, Double-Blind, Randomized, Placebo-controlled Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis” is now posted on www.clinicaltrials.gov (NCT04365868). Galectin Therapeutics will share more details about the protocol at the time the clinical trial begins. In addition, the FDA has received Galectin’s protocol for the hepatic impairment study which will be conducted in subjects with normal hepatic function and subjects with varying degrees of hepatic impairment (NCT04332432). This filing anticipates that this study will also begin in the second quarter of this year.

About Belapectin (GR-MD-02)

Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of fatty liver disease and fibrosis. Galectin-3 plays a major role in diseases that involve scarring of organs including fibrotic disorders of the liver, lung, kidney, heart and vascular system. The drug binds to galectin proteins and disrupts their function. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis.

About Fatty Liver Disease with Advanced Fibrosis and Cirrhosis

Non-alcoholic steatohepatitis (NASH) has become a common disease of the liver with the rise in obesity and other metabolic diseases. NASH is estimated to affect up to 28 million people in the U.S. It is characterized by the presence of excess fat in the liver along with inflammation and hepatocytes damage (ballooning) in people who consume little or no alcohol. Over time, patients with NASH can develop excessive fibrosis, or scarring of the liver, and ultimately liver cirrhosis. It is estimated that as many as 1-2 million individuals in the U.S. will develop cirrhosis as a result of NASH, for which liver transplantation is the only curative treatment available. Approximately 8,890 liver transplants are performed annually in the U.S. There are no drug therapies approved for the treatment of liver fibrosis or cirrhosis.