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First Patient Dosed in Phase II/III COVID-19 Trial
First Patient Dosed in Phase II/III COVID-19 Trial.
About this update from Faron Pharmaceuticals Oy
[{"type":"text","content":"\n \n \n \n RNS Number : 6672J\n Faron Pharmaceuticals Oy\n 25 August 2021\n \n \n \n \n Faron Pharmaceuticals Oy\n \n \n (\"Faron\" or the \"Company\")\n \n \n \n \n \n Faron Pharmaceuticals Doses First Patient in Phase II/III HIBISCUS Trial of Traumakine\n \n \n for Treatment of Hospitalized COVID-19 Patients\n \n \n \n \n \n · \n Trial co-funded by US Department of Defense\n \n \n \n \n \n \n Company announcement, August 25, 2021 at 9.00 AM (EEST)\n \n \n \n \n \n \n \n Inside information\n \n \n \n \n \n \n \n TURKU, FINLAND / BOSTON, MA \n \n - Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company \n focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation\n , today announced that the first patient has been dosed in the Phase II/III HIBISCUS trial assessing Traumakine (Intravenous Interferon beta-1a; IFN beta-1a) as a first-line treatment for hospitalized COVID-19 patients. Traumakine is an investigational therapy 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.\n \n \n \n \n \n The HIBISCUS study will be conducted in approximately 10-15 study sites across the US and will enroll 140 patients who require low flow oxygen support, but not mechanical ventilation. 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 part of the trial protocol, corticosteroid treatment concomitantly with Traumakine is not possible in the study setting but is enabled in a sequenced manner following treatment with Traumakine. The primary efficacy endpoint is clinical status (WHO 9-point ordinal scale) at day 14. Key secondary endpoints for the study include clinical status at day 28 and in-hospital mortality at days 28 and 90.\n \n \n \n \n \n \"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,\n \n M.D., MPH, Chief of Anesthesia, Critical Care and ...