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Patience Pays Off For Galmed Investors...

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Shares of Galmed Pharmaceuticals Ltd. (GLMD) skyrocketed as much as 284% in early trade on Tuesday, and as of this writing are up over 180%, following encouraging top-line, 52-week results from its study dubbed ARREST.

ARREST is a phase IIb clinical trial evaluating the Company's lead product candidate Aramchol in patients with biopsy proven non-alcoholic steatohepatitis, or NASH, who are overweight or obese, and who are pre-diabetic or type-II-diabetic.

NASH refers to liver inflammation due to fat buildup in the liver. In the ARREST study, there was a statistically significant reduction in liver fat as demonstrated by Magnetic Resonance Spectroscopy (MRS) in patients completing 52 weeks of treatment with Aramchol 400mg compared to placebo.

Moreover, significantly more patients treated with Aramchol 600mg vs. placebo showed NASH resolution without worsening of fibrosis in the 52-week biopsy, a regulatory approvable endpoint.

Overall, the data strongly support advancement of Aramchol 600mg to phase III testing, according to the Company.

Things looked completely different some four months back as Galmed stock got no love from investors when the Company reported ARRIVE study results on February 14, 2018. The announcement of the results sent the stock plunging 42.39% to $5.45 that day.

ARRIVE was a proof-of-concept phase IIa clinical trial of Aramchol in patients with HIV-associated Non-alcoholic fatty liver disease (NAFLD) and lipodystrophy, and the study had not met the primary endpoint of improvement of liver fat at 12 weeks, as measured by MRI-PDFF.

Now that the ARREST study has yielded positive results, Galmed plans to meet with the regulators as soon as possible and discuss the pivotal study design.

We had alerted our premium subscribers to GLMD (Report titled "Keen To Prove Worth...) on August 28, 2014, when it was trading around $5.83. The stock, which touched a new high of $27.06 in intraday trading today, is currently up 180.85% at $19.80.

Related Reading:

Race To Find A Treatment For NASH

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