Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD), which is developing a drug for treatment of inflammation caused by fatty liver disease, today announced significant results in reducing fat in the liver in its Phase II trial. The company said that the results made it possible to begin a Phase III trial.
Galmed's share price is currently up 180% in Nasdaq trading. If this level is maintained, it will boost the company's market cap to $300 million.
Galmed's trial was conducted on 246 patients treated with two dosages: 400 milligrams and 600 milligrams; the results of both treatments were compared with a control group. Aramchol, Galmed's drug, reduced the level of fat in the liver in the 400-milligram group by a statistically significant extent. The company said that the change in the 600-milligram group was both statistically and clinically significant (a decrease of more than 5% in the amount of liver fat), although it notes that these results were part of an ad hoc analysis of the result. In an ad hoc analysis, patients who make problems are sometimes removed from the sample and other statistical analyses that reduce the power of the results are sometimes omitted.
The company also reports a significant improvement in the number of patients in whom the inflammation passed with no additional liver scarring. The company says that the US Food and Drug Administration (FDA) is likely to use this measure to approve fatty liver products. There are currently no products in the market for treatment of fatty liver disease, which causes cirrhosis of the liver and cancer of the liver and aggravates the metabolic syndrome characterized by obesity, heart disease, and diabetes.
The fatty liver market is one of the hottest markets in medicine. For example, Madrigal, which recently published unusually good results at a similar trial phase to that of Galmed, has a $4.1 billion market cap.
Galmed cofounder, president, and CEO Allen Baharaff told "Globes" in 2016 that in this field, the very possibility of entering Phase III trials was significant, and that other companies had done this without their results being significant, while their market caps had risen by hundreds of millions of dollars. Baharaff added that a Phase III trial would include 1,400 patients and cost $50-60 million, while successful results in such a trial would probably quintuple the company's share price.
Galmed held its Nasdaq IPO at $13.50 per share, but its share has since lost 50% of its value. The share price reached $20 in preliminary trading, reflecting a 48% return on the share price in the IPO.
Published by Globes [online], Israel business news - www.globes-online.com - on June 12, 2018
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