BIOGGIO, Switzerland–(BUSINESS WIRE)–The KD Pharma Group (“KD Pharma”) and its partner, SLA Pharma (“SLA”), announced that its new drug candidate EPAspire™ is shortly entering clinical trials as a promising candidate to treat patients with symptoms of the novel coronavirus infection. The MHRA in the UK has approved the trial and late-stage discussions are ongoing with authorities in other European countries. Additionally, an application has been submitted to the FDA in the US. It is expected that the first patients in the trial will be enrolled shortly and additional hospital sites are being recruited for the trial.
“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, KD Pharma ’s Chief Executive Officer. Justin Slagel, SLA’s CEO, noted that he and his team are “leading the clinical development to expedite the trials in the various countries working closely with the respective regulatory authorities.” Groet continued, “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.”
Eligible patients with a positive COVID-19 test result will be able to participate in the trial and, after enrolment, 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 unique, novel oral formulation of highly purified eicosapentaenoic acid free fatty acid (EPA-FFA) in gastro-resistant capsules that is delivered to the gut at optimal pH allowing 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 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 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.