Galectin Therapeutics (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announces it has engaged the contract research organization Pharmaceutical Product Development, LLC (PPD) to conduct the Phase 2 trial with GR-MD-02 for the treatment of liver fibrosis and resultant portal hypertension in patients with non-alcoholic steatohepatitis (NASH) cirrhosis (the NASH-CX trial). Galectin also announces it has submitted the protocol for a Special Protocol Assessment (SPA) to the U.S. Food and Drug Administration (FDA) with the goal of accepting the NASH-CX results, if positive, as one of the trials to support approval of the drug candidate.
“We are very pleased to have finalized our engagement of PPD, one of the leading contract research organizations in the world, and are excited to take this step toward the beginning of our Phase 2 program,” said Peter G. Traber, M.D., president, chief executive officer and chief medical officer of Galectin Therapeutics. “PPD’s extensive experience in conducting clinical trials in liver-related diseases will serve us well. We are particularly attracted to their work with clinical trial sites possessing familiarity with hepatic venous pressure gradient (HVPG), as the FDA has indicated that HVPG may serve as a surrogate primary endpoint for NASH cirrhosis. We look forward to the prospect of bringing this new drug to the millions of people in the U.S. with NASH.”
As previously announced, Galectin’s Phase 2 program for GR-MD-02 currently consists of two clinical trials. The NASH-CX trial is designed as a multicenter, randomized, placebo-controlled, double-blind, parallel-group study with 156 patients at up to 60 sites to evaluate the safety and efficacy of GR-MD-02 for the treatment of liver fibrosis and resultant portal hypertension in NASH patients with cirrhosis. Enrollment is expected to commence in the second quarter of 2015, and data readout is expected in the fourth quarter of 2017. In addition, the Company will conduct a smaller trial of shorter duration in 30 NASH patients with advanced fibrosis (the NASH-FX trial). This randomized, placebo-controlled, blinded study will be conducted at Brooke Army Medical Center with enrollment expected to begin in mid-2015 and top-line data readout in mid-2016. In this study, the safety and efficacy of GR-MD-02 on liver stiffness will be evaluated by magnetic resonance-elastography and FibroScan score, and by imaging liver fibrosis using multi-parametric magnetic resonance imaging (LiverMultiScan®, Perspectum Diagnostics).
GR-MD-02 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 scaring 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 GR-MD-02 has robust treatment effects in reversing liver fibrosis and cirrhosis.
About Fatty Liver Disease with Advanced Fibrosis and Cirrhosis
Non-alcoholic steatohepatitis (NASH), also known as fatty liver disease, has become a common disease of the liver with the rise in obesity rates. NASH is estimated to affect up to 28 million people in the U.S. Fatty liver disease is characterized by the presence of fat in the liver along with inflammation and damage in people who consume little or no alcohol. Over time, patients with fatty liver disease can develop fibrosis, or scarring of the liver, and it is estimated that as many as 1-2 million individuals in the U.S. will develop cirrhosis, a severe liver disease for which liver transplantation is the only treatment available. Approximately 6,300 liver transplants are performed annually in the U.S. There are no drug therapies approved for the treatment of liver fibrosis.
Shares of Galectin Therapeutics (GALT) closed yesterday at $3.38 . GALT has a 1-year high of $18.62 and a 1-year low of $3. The stock’s 50-day moving average is $3.56 and it’s 200-day moving average is $4.34.
On the ratings front, Galectin Therapeutics has been the subject of a number of recent research reports. In a report issued on January 6, MLV & Co. analyst Vernon Bernardino maintained a Buy rating on GALT, with a price target of $16, which represents a potential upside of 373.4% from where the stock is currently trading.
According to TipRanks.com, Bernardino has a total average return of -12.6%, a 34.2% success rate, and is ranked 3429 out of 3511 analysts.
Galectin Therapeutics Incis a development-stage company engaged in drug research and development to create new therapies for fibrotic disease and cancer.