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Traumakine update
Traumakine update.
About this update from Faron Pharmaceuticals Oy
[{"type":"text","content":"\n \nRNS Number : 1288C Faron Pharmaceuticals Oy 06 February 2020 \n\nFaron Pharmaceuticals Oy\n(\"Faron\" or the \"Company\")\n \nTraumakine update \n- New trial protocol preventing concomitant corticosteroid use with Traumakine \n- Company notes WHO recommendations on use of steroids in coronavirus patients\n \nCompany announcement, 06 February 2020 at 9.00 AM (EET)Inside information\n \nTURKU - FINLAND - Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today provides an update on Traumakine's clinical continuation following a meeting with the U.S. Food and Drug Administration (FDA) in December 2019. \n \nFollowing feedback from the FDA regarding the design of the next Traumakine study and receipt of agreed meeting minutes, Faron has updated the proposed study design and has submitted the amended trial protocol to the FDA. The trial protocol has been amended to reflect the FDA's feedback that further studies with interferon-beta (IFN-beta) should exclude the use of overlapping steroids since they are likely to block the desired therapeutic effect of Traumakine and may have a potentially deleterious impact on patient outcomes. Faron will continue to work in close collaboration with the FDA to achieve final approval for the next study.\n \nThe Company notes with interest a recent recommendation by the World Health Organization (WHO) that steroids should not be used on coronavirus infected patients1. One of the main first lines of defence against viral infection is endogenous IFN-beta production2. Blocking endogenous IFN-beta production using steroids may be deleterious to treatment outcomes in these patients. Therefore, exogenous IFN-beta (like Traumakine) can strengthen further this endogenous IFN-beta action and provide maximal protection against viral infections but it has to be administered without concomitant corticosteroids, which have the capacity to disturb or block IFN-beta action.\n \nA recent descriptive study published in The Lancet3 on the 2019 novel coronavirus (2019-nCoV) outbreak in Wuhan, China reports that 17% of the 99 patients with 2019-nCoV pneumonia developed Acute Respiratory Distress Syndrome (\"ARDS\") and 11% worsened in a short period of time and died of multi...