4 June 2020 - Deborah Wilkes
A clinical trial in the UK is evaluating the efficacy of Infirst’s Flarin as a treatment for certain symptoms experienced by patients hospitalised with COVID-19.
The team behind the LIBERATE trial said it was a response to “compelling pre-clinical data” for Flarin, a lipid formulated ibuprofen product. The aim is to find out whether effectiveness in humans matches the pre-clinical data.
The trial is a collaboration between Guy’s and St Thomas’ NHS Foundation Trust, King’s College London and the pharmaceutical development company SEEK. The latter has a financial interest in Infirst.
Pre-clinical tests
Infirst said pre-clinical pulmonary inflammation models had shown that the Flarin formulation of lipid ibuprofen was effective in preventing cytokine storm, an over-reaction of the body’s immune system which can lead to hyper-inflammatory conditions such as Acute Respiratory Distress Syndrome (ARDS). This preventative effect was not observed with standard ibuprofen, added the company.
If successful, treatment with Flarin might decrease the need for more aggressive intervention, such as ventilation, and decrease the length of time spent in hospital.
Flarin is a unique formulation of ibuprofen that is available without a prescription in the UK.
Infirst points out that a dose of 1,200 mg/day has been shown to be as effective as 2,400mg/day of standard liquid ibuprofen capsules in patients with acute joint pain. The company also points out that the lipid formulation helps to shield the stomach from damage.
Professor Mitul Mehta from the Centre for Innovative Therapeutics at the NIHR Maudsley Biomedical Research Centre commented: “This trial represents an opportunity to formally test promising results from animal studies and case studies in patients.”
A low-cost treatment
“If successful,” added Mehta, “this trial will provide evidence for a low-cost treatment that could benefit patients in the UK as well as other countries, including lower and middle income countries.”
Professor Matthew Hotopf, director of the NIHR Maudsley Biomedical Research Centre, said this “highly innovative therapeutic approach seeks to rapidly advance a potentially important new treatment”.
“If successful, the global public health value of this trial result would be immense given the low cost and availability of this medicine,” added Hotopf. “The World Health Organization (WHO) and European Medicines Agency (EMA) have highlighted that studies like this are vital in tackling this pandemic.”