Galectin Therapeutics Inc (NASDAQ:GALT), a leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announced the screening of the first five patients in its Phase 2 clinical trial with GR-MD-02 in nonalcoholic steatohepatitis (NASH) with cirrhosis. This study, the NASH-CX trial, is a multicenter, randomized, placebo-controlled, double-blind, parallel-group Phase 2 trial to evaluate the safety and efficacy of GR-MD-02 for the treatment of liver fibrosis and resultant portal hypertension in patients with NASH cirrhosis.
Co-lead investigators are Stephen A. Harrison, M.D., FACP, Colonel, Medical Corps U.S.A., Director, Medical Education, Associate Dean, San Antonio Uniformed Services Health Education Consortium, Professor of Medicine, Uniformed Services University of the Health Sciences Consultant to The Surgeon General for Gastroenterological Diseases, Brooke Army Medical Center /San Antonio Military Medical Center; and, Naga Chalasani, MD, FACG, David W. Crabb Professor & Director, Division of Gastroenterology and Hepatology, Indiana University School of Medicine.
“We are very excited that patient screening has begun in our NASH-CX Phase 2 study, the larger of the two trials comprising our Phase 2 program,” said Peter G. Traber, M.D., president, chief executive officer and chief medical officer of Galectin Therapeutics. “We are delighted that Drs. Harrison and Chalasani have agreed to serve as co-lead investigators, as they are important thought leaders in field of NASH. Indeed Dr. Harrison is an associate editor for Hepatology, the official journal of the American Association for the Study of Liver Diseases, and Dr. Chalasani has well over 100 published papers on NASH and other diseases of the liver.”
“We have worked diligently along with PPD, our contract research organization, to advance to this point in our development. PPD has extensive experience in conducting clinical trials in NASH and cirrhosis, and we are very pleased with the pace of site recruitment. In addition, these sites have experience with measuring hepatic venous pressure gradient (HVPG), our primary endpoint, which is reflective of clinical outcomes in cirrhosis. We will correlate HVPG with liver biopsy as a secondary endpoint both at the beginning and the completion of the 52-week treatment period. In addition, non-invasive tests as secondary endpoints will be conducted at the beginning, middle and end of the study.”
Dr. Traber continued, “Our preclinical research shows that GR-MD-02 binds to Galectin-3, a well-validated target, and our work in preclinical models suggests that GR-MD-02 reverses liver fibrosis and cirrhosis. As a result of the preclinical observations in disease that we noted, we are concentrating our Phase 2 study in the most ill patients – Stage 4 on the NASH spectrum -as these patients have an increased mortality.
“Our two completed Phase 1 trials provide a strong foundation for our NASH Phase 2 program. In a multiple dose-escalation, double-blind, placebo-controlled trial, we found GR-MD-02 to be safe and well tolerated, and noted that the highest dose, 8 mg/kg, may have had an effect on fibrosis as shown by reduced serum alpha-2 macroglobulin, a marker of fibrosis, and reduced liver stiffness as assessed by FibroScan®. In addition, in a drug-drug interaction study between GR-MD-02 and midazolam, a commonly used sedative, there was no interaction, suggesting an additional layer of safety,” Dr. Traber added.
Dr. Traber continued, “The commercial potential of a drug that treats late stage fibrosis and cirrhosis should be excellent. While many other companies are investigating therapeutics in early, low stage fibrosis NASH, we believe that the sense of urgency for treatment by physicians, patients and payors will be less robust than that of late stage NASH with its heightened mortality. In fact, the scope of this disease is such that by 2025 the worldwide market for NASH treatments could approach $35 billion, according to a recent biotech analyst report,” he concluded. (Original Source)
Shares of Galectin Therapeutics (GALT) closed last Friday at $2.56 . GALT has a 1-year high of $16.55 and a 1-year low of $2.51. The stock’s 50-day moving average is $2.88 and its 200-day moving average is $3.32.
On the ratings front, MLV & Co. analyst Vernon Bernardino reiterated a Buy rating on GALT, with a price target of $16, in a report issued on March 19. The current price target implies an upside of 525.0% from current levels.
According to TipRanks.com, Bernardino has a total average return of -4.4%, a 41.9% success rate, and is ranked #3380 out of 3681 analysts.
Galectin Therapeutics Inc is a clinical stage biopharmaceutical company. The Company is engaged in drug research and development to create new therapies for fibrotic disease and cancer.