Galectin Therapeutics Submits Fast Track Application to FDA for GR-MD-02 in Treatment of Fatty Liver Disease with Advanced Fibrosis

Galectin Therapeutics

, the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announced today that it has submitted a Fast Track application to the FDA to help expedite its clinical development program of GR-MD-02 in the treatment of non-alcoholic steatohepatitis (NASH, or fatty liver disease) with advanced fibrosis. FDA grants Fast Track designation to help expedite review and approval of drugs in development that treat serious or life threatening diseases and fill an unmet medical need. GR-MD-02 has shown robust treatment effects in reversing fibrosis and cirrhosis in pre-clinical studies and a phase 1 clinical trial in patients with NASH with advanced fibrosis is currently enrolling. "There are currently no approved medical treatments available for the millions of patients in the US who have NASH with advanced fibrosis," said Dr. Peter G. Traber, President, Chief Executive Officer, and Chief Medical Officer of Galectin Therapeutics Inc. "Fast Track designation from FDA would effectively open many important regulatory pathways to efficiently expedite patient access and will be highly beneficial to advancing the development program for GR-MD-02 in the treatment of NASH with advanced fibrosis." A drug that receives Fast Track designation is eligible for many regulatory benefits from the FDA that can lead to earlier drug approval and access by patients, including more frequent meetings and interactions with the Agency during development to ensure appropriate clinical design and data collection. Drugs receiving Fast Track status are also eligible for Rolling Review, Priority Review, and Accelerated Approval pathways. FDA's Rolling Review process allows a drug company to submit completed sections of its New Drug Application (NDA) for review rather than waiting until every section of the application is completed. Priority Review allows the FDA to reduce the time to review a new drug application, with a completion goal of six months from the 60 day filing date, as opposed to 10 months from the 60 day filing date for the current standard review. An Accelerated Approval pathway is an option for approval based on demonstrating an effect on a surrogate, or substitute endpoint reasonably likely to predict clinical benefit. For further information, please see http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/ucm128291.htm. In accordance with "FDA Guidance for Industry: Fast Track Drug Development Programs —Designation, Development, and Application Review," the Agency will respond to a request for Fast Track designation within 60 calendar days of receipt of the request. A designation letter from FDA will help facilitate the development of GR-MD-02; the purpose of the Fast Track process being to get important new drugs to the patient earlier. About NASH NASH has become a common disease of the liver with the rise in obesity rates, affecting 9 to 15 million people, including children, in the United States. NASH is characterized by the presence of fat in the liver along with inflammation and damage in people who drink little or no alcohol. Over time, patients with NASH can develop fibrosis, or scarring of the liver, and it is estimated that as many as 3,000,000 will develop cirrhosis, a severe liver disease where transplantation is the only current treatment available. Approximately 6,300 liver transplants are done on an annual basis in the United States.