Following the release of positive data involving their drugs GR-MD-02 and GM-CT-01 that are intended to inhibit galectin proteins as a means of treating liver fibrosis shares of Galectin Therapeutics, Inc. (NASDAQ: GALT) spiked to a 52-week high of 5.22 during trading on Monday and while they have dipped down to a current mark of 4.98 they remain well above their 50-day moving average of 3.73 and their 200-day moving average of 2.55.
The data was generated by the laboratory of Dr. Scott Friedman of the Icahn School of Medicine at Mount Sinai and showed that the drugs were able to able to reverse the most advanced stage of liver fibrosis, cirrhosis, in experimental animals given toxin-induced cirrhosis.
Friedman’s findings showed the anti-galectin drugs “had a robust effect on cirrhosis, including reversal of tissue architectural changes in the liver that result from fibrosis as well as reduction in portal hypertension, an important pathophysiological effect of cirrhosis.”
With no current approved medical therapies for this advanced stage of liver fibrosis the news appears to be a major breakthrough for GALT, a company that focuses on developing promising carbohydrate-based therapies for the treatment of fibrotic liver disease and cancer.
Of course today’s announced data, which was presented recently at the International Liver Congress in Amsterdam, The Netherlands, involved rats and while GALT President, CEO and CMO Dr. Peter G. Traber stated “Along with the multiple studies we have presented on liver fibrosis from fatty liver disease, these findings provide added confidence for the potential of this approach in studies of human liver fibrosis and cirrhosis” just how soon they can transition to a study involving human liver fibrosis and cirrhosis is unknown.
That being said, GALT did say that their previously announced initiation of a Phase 1 clinical trial of GR-MD-02 in patients with fatty liver disease (NASH, non-alcoholic steatohepatitis) with advanced fibrosis is expected to begin enrolling patients in May 2013.
There is clearly potential that exists for GALT but when that potential becomes a reality remains a big question. While GALT received a nice bump in their share price today there is still a long way to go before they successfully navigate their way through the clinical trials that will earn them an FDA approval.