The UK’s MHRA has approved a clinical trial for a novel drug candidate from KD Pharma Group (“KD Pharma”) and its partner, SLA Pharma (“SLA”) to treat patients with symptoms of novel coronavirus infection. The MHRA in the UK has approved the clinical trial and late-stage discussions are ongoing with authorities in other European countries. The duo also submitted an application to the FDA in America. The UK biotech sponsors hope to commence the trial targeting COVID-19 shortly. The sponsors are actively recruiting hospital sites.
Another Therapy Targeting ARDS & Related Complications
A number of experimental therapies, and for that matter repurposed ones, are targeting COVID-19 and ARDS related conditions. Although the actual COVID-19 death rate is not yet fully known (situation still unfolding), it is apparent that when the virus’ respiratory infection worsens severe and deadly consequences are of great concern.
What is EPAspire™?
The sponsor reports that the use of the drug should reduce the risk of COVID-19-related serious outcomes such as ARDS or the need for ventilation and intensive care reported KD Pharma’s CEO Oscar Groet. EPAspire is made of purified eicosapentaenoic acid free fatty acid (EPA-FFA) in gastro-resistant capsules. The drug is delivered to the gut at optimal pH to ensure maximal absorption.
Since the drug is currently in a Phase III trial for FAP in multiple countries, the companies have been able to initiate the COVID-19 test result rapidly. The sponsors report a well-established safety profile from previous studies.
Eligible patients afflicted with 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 currently in a clinical trial in Europe for the treatment of familial adenomatous polyposis (FAP). Proprietary data from the FAP trials suggests it suppresses expression of inflammatory cytokines believed to contribute to the progression of COVID-19 symptoms. Since the drug is currently in a Phase 3 trial for FAP in multiple countries, the companies have been able to initiate the COVID-19 trials very rapidly. The safety profile of EPAspire™ is well established from previous clinical studies.
Italian Principal Investigator Observation
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. “EPA as a free fatty acid is very promptly absorbed and incorporated into the body’s phospholipid membranes, and then starts to act very quickly. Once incorporated into cell membranes, EPA-FFA significantly affects the production of pro-inflammatory mediators such as IL-6 and leukotriene B4 that play a crucial role in starting and maintaining the inflammatory process in the lungs. Moreover, EPA-FFA metabolism generates pro-resolving mediators and bioactive metabolites, that enhance innate microbial killing and organ protection,” they noted.
About KD Pharma Group SA
The KD Pharma Group SA is a contract manufacturer that develops products in the pharmaceutical and nutraceutical space. It is also one of the largest Omega-3 fatty acid producers in the world with 500 employees and a presence in the UK, Norway, Germany, Switzerland, and the US. The KD Pharma Group employs state-of-the-art technology, which is protected by numerous patents
SLA Pharma AG is one of the few pharmaceutical companies in the world focused on developing medicines for the prevention and treatment of inflammatory, immune and gastrointestinal (GI) disorders, such as familial adenomatous polyposis (FAP), non-healing pilonidal sinus (PNS), anal fissures, inflammatory bowel disease and complications related to viral infections.