Amarin Corporation PLC announced news early this morning that positive, statistically significant data has been received from its MARINE study with its lead drug candidate, AMR101. This study, the largest controlled therapeutic trial ever from patients with very high triglycerides, which is being performed in accordance with SPA (Special Protocol Assessment) with the U.S. Food and Drug Administration, has met its primary efficacy endpoints as defined in the clinical trial protocol.
For those not fully aware of what triglycerides are and what they do, the long and short of it is as follows. Triglycerides are a type of fat found in your blood. Your body uses them for energy, but too many triglycerides can raise the risk of heart disease and are often associated with metabolic syndrome, which is a combination of high blood pressure, high blood sugar, low HDL (“good”) cholesterol and high triglycerides. Normal triglyceride levels are less than 150 mg/dL (milligrams per deciliter). Very high levels are in excess of 500 mg/dL. High triglycerides typically do not cause symptoms, but are brought on by other conditions such as obesity, an underactive thyroid, kidney disease, poorly controlled diabetes or alcohol abuse, amongst other things.
Amarin’s trials are based on patients with triglyceride levels in the “very high” category, meaning levels in excess of 500 mg/dL. The baseline levels for the different groups in the trials were significantly higher than the 500 marker. The study's primary endpoint, the percent change in triglyceride (TG) levels from baseline to week 12, was met for both the 4 gram and 2 gram dose groups. The MARINE study was required to meet a stringent level of statistical significance of 1% (p < 0.01), as agreed in the Company's SPA with the FDA.
Not only did the patients treated with AMR101 see a decrease in triglyceride levels, but also very notable was that there was not an increase in median LDL-C compared to placebo at either dose (-2.3% for the 4 gram group and +5.2% for the 2 gram group [p=NS]). LDL is a class of plasma lipoproteins that transport cholesterol to extrahepatic tissues, in which high levels have been correlated with premature coronary heart disease. This is the first and only triglyceride-lowering therapy studied in this population with very high triglyceride levels to show a lack of elevation in LDL-C. In fact, there was a statistically significant decrease in median non-HDL-C (total cholesterol less "good cholesterol") compared to placebo with both of the AMR101 treated groups (-18% for the 4 gram group [p < 0.001] and -8% for the 2 gram group [p < 0.05]).
Due to the promising data and the significant are of unmet need in pharmaceutics to treat high triglycerides, Amarin feels that it is well-positioned with AMR101 to provide the best-in-class product for this indication and that the MARINE study results may support additional patentable claims that could further protect the Company's rights to this product through 2030. Amarin intends to file a NDA (New Drug Application for AMR101 in 2011 in attempt to bring the new drug to market.
Shares of AMRN are trading up 60.57% to $5.70 this morning on extremely high volume with over 14 million shares traded already today.
More information on Amarin and its drugs in development can be found on the Company’s website at www.amarincorp.com.
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