A promising coronavirus treatment derived from fish oil is expected to begin clinical trials in around a month after getting the green light from the UK's Medicines and Healthcare Regulatory Agency (MHRA).
Approval is also being sought from the US Food and Drug Administration (FDA), as well as in Spain, Italy and Israel.
The formulation, developed in partnership between KD Pharma and SLA Pharma, is classified as neither prevention nor cure.
Capsules, which contain a trademarked formulation, are taken orally.
In the study, the pills will be given to patients that have contracted coronavirus, with the aim of minimizing symptoms to reduce the risk of coronavirus complications progressing to serious outcomes such as the need for artificial ventilation and intensive care.
"We are hoping that by giving it to them early enough when they get into the hospital that it will prevent their progression to those type of outcomes," KD Pharma Group Chief Strategy Officer Adam Ismail told IntraFish.
"It isn't thought to be anti-viral, but the goal is to minimize the symptoms of the infection and thus prevent their progression to more serious care."
Eligible patients with a positive Covid-19 test result will be able to participate in the trial and, after enrollment, will be given the product within a day of hospitalization and continue treatment for one month with a two-week follow up.
They will be monitored for progression to more serious outcomes and signs of inflammation, with the aim that the treatment could help reduce the risk of mortality in severely ill patients.
EPAspire, as the supplement is called, is a formulation of highly purified eicosapentaenoic acid free fatty acid (EPA-FFA) capsules.
It is currently undergoing separate clinical trials in Europe for the treatment of a type of colon cancer known as familial adenomatous polyposis (FAP).
The fish oil used in the formula is produced from pelagic species.
With more than 100 products being trialed to combat coronavirus, Ismail said those conducting clinical trials will be looking to treatments and drugs that are considered safe as well as effective as they weed out candidates to combat coronavirus.
"Based on EPA, which has a pretty well known safety profile, and in comparison to some of the other drugs, we think it may have a preferential safety profile," he said.
An extension to long-known benefits
Research into the benefits of omega-3 fish oil containing fatty acids on the human body is not new.
Long‐chain polyunsaturated fatty acids (PUFAs) are recognized as mediators of inflammation and adaptive immune responses. Omega‐3 and omega‐6 PUFAs help to promote anti‐inflammatory and pro‐inflammatory effects.
Researchers who have previously studied potential use for these omega-3 containing fatty acids as a treatment for flu, HIV, other viral infections, microbial pathogens and immune cells are also keen to discover whether they could be used to intervene against coronavirus.
A scientific review of 12 clinical trials including 1,280 patients found that omega-3 fatty acid supplementation may improve lung function and reduce the need for ventilators in those with acute respiratory distress syndrome.
The Global Organization for EPA and DHA (GOED) says science does not support the claim that consuming omega-3 rich products containing fish oil will boost immunity against coronavirus.
Based on its own research, GOED concluded there is an insufficient body of scientific literature to connect EPA/DHA to benefits of either positive general or viral immunity outcomes in a healthy population.
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