AstraZeneca stops Epanova trial early due to disappointing results

U.K.-based drug giant AstraZeneca announced Jan. 13 it would be halting its Phase III trial of Epanova, a medication comprised of omega-3 carboxylic acids, early due to disappointing data.

The company made the call following a recommendation from an independent Data Monitoring Committee, according to a statement. The committee pushed AstraZeneca to shutter the trial after preliminary data showed Epanova had a “low likelihood” of benefiting patients with mixed dyslipidemia and an increased risk of CVD.

“It was important to assess the potential benefit of Epanova in mixed dyslipidemia,” Mene Pangalos, executive vice president, BioPharmacuticals R&D at AstraZeneca, said in a statement. “We are disappointed by these results, but we remain committed to addressing the needs of patients in the cardiovascular space where we have an extensive pipeline.”

The Phase III STRENGTH trial enrolled 13,086 patients across 675 sites in 22 countries, randomizing them to either 4 grams of Epanova daily or a placebo, which was corn oil. The study’s main goal was to discern whether the drug could reduce the risk of major adverse cardiovascular events in patients with mixed dyslipidemia who were already on optimal statin therapy but remained at a high risk of CVD.

Epanova itself, according to AstraZeneca, is a fish oil-derived blend of free fatty acids primarily composed of EPA and DHA. Right now it’s approved in the U.S. as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia—an indication the STRENGTH researchers said won’t be affected by the trial’s abrupt end.

“The academic leadership of the STRENGTH trial is obviously disappointed in this result, but we are very proud to have had the opportunity to answer this important scientific question,” Steven E. Nissen, MD, study chair for the STRENGTH trial and chief academic officer for the Heart and Vascular Institute at the Cleveland Clinic, said in a statement. “We are also grateful for the opportunity to conduct the STRENGTH trial as an exemplary collaboration between academic physicians and industry.”

According to AstraZeneca, the trial will be closed “in an orderly fashion,” and full results will be presented at a future medical meeting. The company expects a $100 million writedown, and a review is reportedly being undertaken regarding the ongoing value of the $533 million Epanova intangible asset.