Clinical trial for treatments containing omega-3 fatty acids initiated
The KD Pharma Group and its partner SLA Pharma announced lasts week its new drug containing omega-3 fatty acids, EPAspire, is entering clinical trials as a potential treatment for patients with symptoms of the novel coronavirus (COVID-19).
The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has moved to expedite trials of the drug, while discussions with authorities in other European countries are underway, the companies said. Additionally, an application has been submitted to the U.S. Food and Drug Administration for emergency use authorization in the United States.
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 markers of inflammation, with the aim that EPAspire could help reduce the risk of mortality in severely ill patients.
EPAspire is a novel oral formulation of highly-purified eicosapentaenoic acid free fatty acid (EPA-FFA), and comes in gastro-resistant capsules. The drug is currently in a phase 3 clinical trial in Europe for the treatment of familial adenomatous polyposis (FAP), contributing to KD Pharma, one of the world’s largest omega-3 fatty acid producers, and SLA being able to initiate COVID-19 trials “very rapidly,” according to company representatives.
The primary investigators in Italy who designed the protocol believe EPA-FFA may change the course of SARS-CoV-2 infections by modulating immune response and protecting patients from its most severe complications. It is expected that the first patients in the trial will be enrolled shortly and additional hospital sites are being recruited for the trial, the companies said.
“We hope EPAspire will be able to reduce the risk of coronavirus complications progressing to serious outcomes like ARDS, the need for artificial ventilation and intensive care,” said Oscar Groet, chief executive officer of KD Pharma, in a press statement. “This unique preparation has potential, to not only modify the COVID-19 disease process, reducing harmful, excess inflammatory responses, but to do so without suppressing the immune response to the virus which are vital to seroconversion giving the patient ongoing protection against continued viral challenge.”