An experimental medicine lowered fatty chemicals in the blood by as much as 45 per cent in a final-stage clinical study, Irish-American biopharmaceutical company Amarin said today.
Patients with triglyceride levels of more than 750 milligrams per deciliter of blood who were given a four-gram dose of AMR101 saw the blood fat reduced by 45 per cent compared with patients taking a placebo, Amarin said.
Such patients taking a two-gram dose had a reduction of 33 per cent, Amarin said. Triglycerides are a type of fat that can lead to heart disease when found in the blood at high levels.
AMR101 is an omega-3 fatty acid sourced from certain fish oils and would compete with GlaxoSmithKline's Lovaza, the only omega-3-based prescription drug approved in the US. Lovaza generated sales of €533 million for the UK company last year.
Amarin said today it will ask US regulators to approve the medicine next year, earlier than its original forecast of a 2012 submission.
"We believe that these results and the overall profile of AMR101 position the drug candidate to be best in class in this market," said Joseph Zakrzewski, Amarin chief executive.
More than 3.8 million people in the US have high triglyceride levels, he said.
Amarin rose 60 cents, or 17 percent, to $4.15 in trading before the Nasdaq Stock Market opened. Before today, the stock had more than doubled this year, giving the company a market value of $350.8 million.
The trial, dubbed Marine, is the first of two final-stage studies looking at patients with very high triglyceride levels. The study found that overall, patients treated with a four-gram dose of the drug had a 33 percent reduction in triglycerides, compared with a 20 percent reduction in patients taking a two-gram dose.
The study looked at 229 patients over 12 weeks. The drug didn't significantly increase low-density- lipoprotein cholesterol, the company said.
Similar treatments may raise cholesterol by 40 to 50 per cent in patients with high triglycerides, Harold Bays, medical director at Louisville Metabolic and Atherosclerosis Center and principal investigator of the study, said in the statement. The second study, dubbed Anchor, is likely to finish enrolling 650 patients before Christmas, Amarin spokesman Mark Swallow said.
Amarin had net cash outflows of $6.2 million in the three months ended September 30th, with $5.5 million paid in connection to the two clinical trials. Amarin's net loss nearly tripled to $59 million last year from $20 million a year earlier. The company hasn't generated any revenue in three years, compared with $500,000 in 2006.
Last year Dublin based Fountain Healthcare Partners lead a $70 million investment into Amarin at the height of the economic down turn. Other investors in the round included international life science venture capital firms such as Abingworth, Orbimed, Sofinnova and LifeSciences Partners.
Bloomberg