Faron Pharmaceuticals (FARN ) has dosed the first patient of a Phase II/III trial which will assess the effects of one of the group’s products in patients hospitalised with COVID-19.  

The biopharmaceutical firm, which is focused on tackling cancer and inflammation through immunotherapy, said the HIBISCUS trial will assess Traumakine, the Group’s investigational intravenous (IV) interferon beta-1a therapy, in patients hospitalised with COVID-19. 

Traumakine is an investigational therapy which was developed by Faron for the potential treatment of acute respiratory distress syndrome (ARDS), acute kidney injury, cardiac protection, prevention of solid organ transplant failure and ischemia reperfusion injury. 

The HIBISCUS study will be conducted in around 10-15 study sites across the US and will enroll 140 patients who require low flow oxygen support, but not mechanical ventilation. 

Faron said patients will be randomized 1:1 across two study arms to assess the safety and efficacy of Traumakine compared to corticosteroid treatment with dexamethasone. 

As is protocol, corticosteroid treatment concomitantly with Traumakine is not possible in the study setting but is enabled in a sequenced manner after treatment with Traumakine. 

Faron, which received $6.1m of funding from the Coronavirus Aid, Relief, and Economic Security Act earlier this year the US Department of Defense, said the primary efficacy endpoint is clinical status (WHO 9-point ordinal scale) at day 14 while key secondary endpoints include clinical status at day 28 and in-hospital mortality at days 28 and 90. 

Shares in Faron Pharmaceuticals have nearly doubled in value since the beginning of 2021. The stock was trading 4.40% higher during the late morning at 475p following the news. 

"There are currently limited treatment options for hospitalized COVID-19 patients, many of whom spend months in the hospital and face the potential of lifelong complications associated with their disease," said Daniel S. Talmor, M.D., MPH, Chief of Anesthesia, Critical Care and Pain Medicine at Beth Israel Deaconess Medical Center and Principal Investigator of the trial. 

Talmor, who described the trial as “pivotal”, believes intravenous IFN beta-1a has the potential to become a powerful treatment option for patients who are at risk of developing acute respiratory distress syndrome as a result of a viral infection, such as COVID-19. 

Commenting on the HIBISCUS trial, Dr. Markku Jalkanen, CEO of Faron Pharmaceuticals said: "Despite the progress that has been made with vaccinations, there remains a critical need to identify effective treatment options for hospitalized COVID-19 patients.” 

As we continue to gain insight into the potential benefit of IFN beta-1a as the body's first line of defense against viral infection, we believe Traumakine will be advantageous over current standard of care to protect lung function post COVID-19 infection.” 

Additionally, as part of the US Department of Defense’s (DoD) ongoing working relationship established with Faron, the 59th Medical Wing of the US Air Force and the DoD are continuing preclinical studies to evaluate Traumakine's role in preventing multiple organ dysfunction syndrome (MODS) after ischemia-reperfusion injury caused by a major trauma. 

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