Global pharmaceutical firm AstraZeneca is abandoning a fish oil-based drug trial because of its “low likelihood” of benefitting patients with an increased risk of cardiovascular disease, the company announced on 13 January.
“It was important to assess the potential benefit of Epanova in mixed dyslipidaemia [those with higher than normal levels of cholesterol, triglycerides and other lipids in the blood],” said Mene Pangalos, executive vice president of bio-pharmaceuticals R&D at AstraZeneca. “We are disappointed by these results but we remain committed to addressing the needs of patients in the cardiovascular (CV) space.”
The Phase III Strength trial for Epanova was evaluating the effect of 4g/day of the capsule, compared to a corn oil placebo, on reducing the risk of major adverse CV events in patients on statin therapy with mixed dyslipidaemia (MDL) who were at high risk from CV disease. It was carried out on 13,086 patients in 22 countries.
“MDL includes patients with raised triglyceride levels between 175-499 milligramme/decilitre (mg/dL) and low HDL [good] cholesterol,” Astra Zeneca said. “Elevated triglycerides affect a growing number of patients and is often worsened by other factors such as diabetes or obesity. Lifestyle changes and potentially treating the underlying cause is likely to at least partly improve the condition and reduce cardiovascular risk.”
Epanova contains a free fatty acid formulation of the omega 3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
According to the Motley Fool, Epanova won US Food and Drug Administration (EPA) approval in 2014 as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia, a condition where triglyceride levels are 500mg/dL or more.
“This indication is not impacted by the data from the Strength trial,” AstraZeneca said.
The company acquired Epanova with its takeover of Omthera Pharmaceuticals in 2013 but it faced intense competition from other fish oil drugs on the market and also faced legal challenges, with US pharma firm Amarin suing AstraZeneca over alleged patent infringements in 2014.
“The discontinuation of the Strength study means that Epanova won’t become the big winner AstraZeneca hoped it would be,” the Motley Fool said.