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Amarin Corporation plc (NASDAQ: AMRN) shares were falling Monday following the presentation of detailed primary results from the the late-stage REDUCE-IT study that evaluated Vascepa, held at a late-breaking session at the 2018 Scientific Sessions of the American Heart Association in Chicago.
Efficacy Confirmed
Amarin said the Phase 3 trial confirmed 25-percent relative risk reduction, or RRR, which is the primary endpoint, with multiple robust demonstrations of efficacy, including a 20-percent reduction in cardiovascular death.
The REDUCE-IT trial was a global study of 8,179 statin-treated adults with elevated cardiovascular risk, and it studied Vascepa 4gm/day as compared to placebo over a median follow-up time of 4.9 years.
The company said the key secondary endpoint was achieved, with 26-percent RRR with respect to cardiovascular death, non-fatal heart attack and non-fatal stroke, while seven additional secondary endpoints were also met.
Amarin’s Vascepa capsules are chemically icosapent ethyl and contain Omega-3 acid known as EPA in ethyl-ester form. The drug, codenamed AMR101, is derived from fish, though it is not fish oil.
Vascepa was approved by the FDA in 2012 to treat high levels of triglycerides in blood, and data from the recent trial is intended to be used to support a regulatory filing for the expanded indication of improving cardiovascular outcomes.
Top-line results released Sept. 24 showed a 25-percent RRR, with a high degree of statistical significance in major adverse cardiovascular events in the intent-to-treat patient population. The announcement sent its shares up by 314 percent in a single session to $12.40.
Since then, the stock has gained a whopping 600 percent.
Placebo Concerns
The placebo used in the trial was filled with mineral oil that may have caused heart problems for the patients in the control arm, according STATNews biotech reporter Adam Feuerstein.
This may take some sheen off the strong cardiovascular benefit data from the treated arm, he said in a Saturday story.
“What we see is a substantial reduction in cardiovascular events, but how much is attributable to [Vascepa] and how much to the possible harm caused by the mineral oil?” said University of California cardiologist Ethan Weiss, according to Feuerstein.
“I can talk myself into believing this question is not a big deal, but it’s there and that makes the data messy and a little disappointing.”
Some of the weakness in the stock could also be due to profit-taking following the strong gains.
The stock was down 13.33 percent at $18.24 at the time of publication Monday.
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The Week Ahead In Biotech: Earnings, Conferences, PDUFA Dates, Clinical Trial Results And IPOs
Attention Biotech Investors: Mark Your Calendar For These November PDUFA Dates
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