KD Pharma and its partner, SLA Pharma, have announced that its new drug candidate, EPAspire, will be used in clinical trials as a possible candidate to treat patients with COVID-19 symptoms. The MHRA in the U.K. has approved the trial nad late-stage discussions are going on with authorities in other European countries, and an application has been submitted to the U.S. Food and Drug Administration (FDA).
EPAspire’s main active ingredients are EPA free fatty acids and a sweet wormwood extract.
“We hope EPAspire will be able to reduce the risk of coronavirus complications progressing to serious outcomes like ARDS (Acute Respiratory Distress Syndrome), the need for artificial ventilation, and intensive care,” Oscar Goet, KD Pharma CEO. “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 is cvital to seroconversion giving the patient ongoing protection against continued viral challenge.”
SLA reports that it is “leading the clinical development to expedite the trials in various countries working closely with the respective regulatory authorities,” SLA CEO Justin Slagel said.
Eligible patients with a positive COCVID-19 test result will be able to participate in the trial, and, after enrollment, will be givent 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 unique, novel formulation of highly purified EPA free fatty acid in gastro-resistant capsules which deliver it to the gut at optimal pH to allow for maximal absorption. EPAspire is currently in a clinical trial in Europe for the treatment of familial adenomatous polyposis (FAP). Proprietary data from the FAP trials suggests that 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.
The primary investigators in Italy who designed the protocol believe EPA-FFA may change the course of COVID-19 by modulating immune response and protecting patients from its most severe complications.
“EPA is a free fatty acid that is very promptly absorbed and incorporated into the body’s phospholipid membranes, and then starts to act very quickly,” the investigators wrote. “Once incorporated into cell membranes, EPA-FFA significantly affefcts 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.”