Fish-oil-derived drug fails in massive final phase human trial
Pharma company AstraZeneca has discontinued a large Phase 3 clinical trial into the efficacy of a fish-oil-derived drug called Epanova. The drug had been previously approved by the FDA to treat patients with very high triglyceride levels but this trial was designed to establish the broader use of the drug as an adjunct to conventional statin therapy for heart disease.
A variety of studies in recent years have reported mixed results for omega-3 fish oil supplements effectively reducing the risk of cardiovascular disease and stroke. A massive metastudy in 2018 found no evidence that omega-3 supplementation conferred protective benefits against coronary heart disease or reduced all-cause mortality.
Several pharmaceutical companies have been working to show that certain fatty acids found in fish oil can be purified, concentrated, and turned into targeted medicines. In December 2019 a drug called Vascepa was approved by the FDA for broader cardiovascular treatments after an advisory panel recommended its efficacy as an adjunctive treatment to regular statin therapy.
Vascepa is a purified concentrated form of one particular fatty acid found in fish oil, called eicosapentaenoic acid (EPA). Epanova, on the other hand, is a combination of EPA and a second omega-3 fatty acid called docosahexaenoic acid (DHA).
Both drugs have been previously approved by the FDA to only treat patients with very high trigliceride levels. The race had been on for several years to complete larger clinical trials in the hopes of gaining official approval for the drugs to be used more broadly as a heart disease treatment.
The failure of Epanova in this large Phase 3 trial comes after an independent data monitoring committee evaluated the data following over 13,000 patients. The trial, called STRENGTH, spanned 22 countries and was investigating Epanova’s efficacy in reducing the risk of major adverse cardiovascular events in association with statin therapy, compared to a placebo.
The full trial data is promised to be presented at a future medical meeting. It has been suggested that the addition of DHA in Epanova could be what was compromising its efficacy, explaining why Vascepa’s simple EPA formulation has been successful while this similar fish-oil-derived formulation has failed.
“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,” says Steven Nissen, Study Chair of the STRENGTH trial. “We are also grateful for the opportunity to conduct the STRENGTH trial as an exemplary collaboration between academic physicians and industry.”