Amarin (NASDAQ:AMRN) said Monday it will present the positive results from the MARINE and ANCHOR studies of its AMR101 drug, intended for the treatment of high triglyceride levels, at the American Heart Association's Scientific Sessions in Orlando, Florida.
Both studies are phase three, and each investigated the effects of the company's AMR101 drug, for which a new drug application (NDA) was submitted to the U.S. FDA in late September.
During the trials, AMR101 achieved all primary endpoints, including tolerability in comparison to a placebo.
The AMR101 drug is a prescription-grade omega-3 fatty acid, comprising at least 96 percent ultra pure ecosapent ethyl, and is intended for the treatment of patients with very high triglyceride levels. In addition to this intended treatment, AMR101 has the potential to be the first therapy approved for patients that are simultaneously being treated for high levels of cholesterol in the blood.
Triglycerides are a type of fat found in the blood used to store excess and unused calories, and too much of this fat can contribute to the hardening and narrowing of arteries, which can lead to diabetes, heart disease, and stroke. The levels of these fats in the bloodstream are classified into four categories: normal, borderline high, high, and very high.
In the U.S. alone, it is estimated that 75 million people have at least 'borderline high' levels of triglycerides, including 4 million people with 'very high' levels.
On the Nasdaq Exchange, Amarin shares traded up 4.06 percent to $7.44, as of 11:52 am EDT.