RE: Rns20 May 2020 08:11
TURKU - FINLAND - Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, announces today that the results of its detailed analyses into the effects of glucocorticoids on intravenous (IV) interferon (IFN) beta-1a activity, which arose following the INTEREST trial in 2018, have been published in Intensive Care Medicine, a world leading journal in the field of critical care.
The results showed that the desired mechanism of action of IV IFN beta-1a in the lung vasculature - the upregulation of CD73 - is blocked by the administration of glucocorticoids. In addition, the administration of glucocorticoids with IV IFN beta-1a increases mortality in patients with acute respiratory distress syndrome (ARDS) compared to patients administered with IV IFN beta-1a alone. As previously announced, analysis from the INTEREST trial showed Day-28 mortality for patients receiving concomitant glucocorticoids with IV IFN beta-1a was 39.7% compared to 10.6% for patients receiving IV IFN beta-1a alone (p < 0.001).
Dr. Markku Jalkanen, Faron's CEO, said: "This is a crucial publication for the critical care community, detailing the important scientific detective work that has been undertaken since the unexpected readout from the INTEREST trial. It is especially important in these times when ICUs are filled with COVID-19 patients, many of whom may be receiving treatment with glucocorticoids. Prior clinical data have shown that glucocorticoids are harmful in viral-induced ARDS and the World Health Organization has already recommended not to use glucocorticoids in severely ill COVID-19 patients. These published and peer-reviewed data give us the mechanistic reason why and the results are without dispute. The potential lung protective effects of interferon beta through upregulation of CD73, should it be endogenous or exogenous, are lost with the administration of glucocorticoids."
In recent weeks Faron has announced that its investigational IV IFN beta-1a (Traumakine) is being trialled in two global studies investigating potential COVID-19 treatments - the World Health Organization (WHO) Solidarity study, involving over 90 countries, and the global REMAP-CAP trial (Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia) underway across close to 200 sites in 14 countries. The Company continues to develop Traumakine as a treatment for ARDS patients. As previously announced, in March the U.S. Food and Drug Administration (FDA) accepted the Company's proposed protocol design for the next Traumakine study, which will exclude the use of concomitant glucocorticoids.
"Glucocorticoids inhibit type I IFN beta signaling and the upregulation of CD73 in human lung" in Intensive Care Medicine can be found here.
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