Shares of Anthera Pharmaceuticals Inc. (ANTH) plummeted 55 percent in after-hours trade Friday, after the company said it halted the Phase 3 clinical study of its heart drug varespladib methyl.
The Phase 3 study, Vista-16, is an event driven trial evaluating varespladib methyl in combination with Lipitor to reduce secondary Major Adverse Cardiovascular Events in patients who recently experienced an Acute Coronary Syndrome, or ACS - a disease involving the coronary arteries.
Anthera's decision to abandon the Vista-16 study was based on a recommendation by the VISTA-16 Data Safety Monitoring Board, which cited lack of efficacy that could not be overcome in the remainder of the trial.
Anthera said it has closed enrollment in the phase 3 VISTA-16 study and informed investigators to remove patients from therapy.
Varespladib is a potent oral inhibitor of a number of pro-inflammatory enzymes collectively known as secretory phospholipase A2, or sPLA2.
Elevated levels of sPLA2 have been implicated in a variety of acute inflammatory conditions, including ACS, and are associated with an increased risk for future ischemic events, such as a heart attack or even death.
Anthera has worldwide product rights to varespladib, except in Japan where Shionogi & Co., Ltd. retains rights.
The late stage study of varespladib was commenced last June. The study was designed to enroll 6,500 high-risk acute coronary syndrome patients across 15 countries.
The primary endpoint of the study pertained to a reduction in major adverse coronary events like cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or documented unstable angina with objective evidence of ischemia requiring hospitalization.
Anthera is a development-stage company, and to date, has not generated any revenue. In the recent fourth quarter, its net loss widened to $29.2 million or $0.71 per share from a loss of $13.0 million or $0.40 per share last year.
The company's pipeline includes A-623. The study, PEARL-SC, is examining the therapeutic benefit of weekly and monthly subcutaneous injections of blisibimod in patients with active and antibody positive systemic lupus erythematosus.
Anthera recently said it would continue the Phase 2b PEARL-SC clinical study. The company expects top-line efficacy data from the PEARL-SC clinical study in the second quarter 2012.
Anthera's third product candidate is A-001, which has completed a phase II clinical study for the prevention of acute chest syndrome associated with sickle cell disease.
Anthera went public in March 2010, offering its shares at a price of $7.00 each. Anthera shares closed Friday on the Nasdaq at $6.42, up $0.28 or 4.56%. In after hours, the stock dropped $3.55 or 55.30%.
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