The stock price is cratering for thinly-traded Tel Aviv company Galmed Pharmaceuticals $GLMD, which just announced a Phase IIa letdown of its non-alcoholic fatty liver disease program.
The mid-stage study was evaluating Aramchol in 50 patients with HIV-associated lipodystrophy and non-alcoholic fatty liver disease. The study, called Arrive, failed to meet the primary endpoint of an improvement in liver fat at week 12.
Aramchol is a bile acid conjugate that the company says modulates hepatic lipid metabolism, down-regulating the three main pathologies of NASH: steatosis (abnormal retention of fats in cells), inflammation, and scarring.
Data from this trial will likely be used as a read-through to the upcoming Phase IIb results from a different study (called Arrest) evaluating the drug in 248 patients with NASH, according to a research note from SunTrust’s senior biotech analyst Edward Nash.
“While there is a chance that the company could be successful in the Arrest trial given that patients in that trial are not HIV+, we do not believe the Street will make this distinction as it is only hypothesized that the pathophysiology of HIV disease could impact the course of non-alcoholic fatty liver disease,” Nash wrote in an email.
The Arrest data are expected in the second quarter of this year.
Galmed’s stock is down over 63% in pre-market trading Wednesday.
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