Sign up here for GlobalData's free bi-weekly Covid-19 report on the latest information your industry needs to know.
KD Pharma Group and SLA Pharma are set to conduct a clinical trial of drug candidate EPAspire to potentially treat Covid-19 symptoms.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved the trial, which will investigate the ability of the drug candidate to decrease the mortality risk in severely ill patients.
The companies are currently in discussions with authorities in other European countries. An application has been filed with the US Food and Drug Administration (FDA).
Enrolment for the trial is set to begin soon and more hospital sites are being added.
KD Pharma CEO Oscar Groet 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.
“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.”
EPAspire is made of purified eicosapentaenoic acid free fatty acid (EPA-FFA) in gastro-resistant capsules. It is delivered to the gut at optimal pH to ensure maximal absorption.
Trial participants will receive the drug candidate within one day of hospitalisation and the treatment will be continued for one month with a follow-up of two weeks.
Patients will be assessed for disease progression to more serious outcomes and inflammation markers.
EPAspire is currently in a clinical trial in Europe to treat familial adenomatous polyposis (FAP).
The company said that the FAP trial data indicates that the drug candidate suppresses expression of inflammatory cytokines, which are thought to be associated with the progression of Covid-19 symptoms.