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Results from the Japanese Phase III study
Results from the Japanese Phase III study.
About this update from Faron Pharmaceuticals Oy
[{"type":"text","content":"\n \nRNS Number : 3231X Faron Pharmaceuticals Oy 29 April 2019 \n\nFaron Pharmaceuticals Ltd\n(\"Faron\" or the \"Company\")\n \nResults from the Japanese Phase III study with Traumakine in the treatment of ARDS\n \nTURKU - FINLAND, 29 April 2019 - Faron Pharmaceuticals Ltd (\"Faron\") (AIM: FARN), the clinical stage biopharmaceutical company, today announces that its Japanese licensing partner Maruishi Pharmaceutical Co., Ltd. (\"Maruishi\") has provided clinical trial results on its Phase III Japanese Traumakine® study for the treatment of acute respiratory distress syndrome (\"ARDS\"). \n \nThe results of the trial are in line with Faron's expectations which were detailed in the Proposed Placing announcement on 26 March 2019. In particular: \n \n\nTreatment with Traumakine did not result in reduced mortality or increased number of ventilator free survival days when compared to placebo. \nOverall, the placebo and Traumakine treatment groups were well balanced in basic demographics, except that the Traumakine group had more sepsis and less pneumonia as the etiology of ARDS when compared to the placebo group.\n\n \nAccording to the post-hoc analysis, the overall percentage of study subjects who received concomitant glucocorticoids was 77%, which was higher than that of the INTEREST study. The effect of glucocorticoids showed similar trends to that observed from the INTEREST study. Due to the limited trial size, further sub-group analysis is not meaningful.\n \nDr Markku Jalkanen, CEO of Faron, said: \"As we had already observed in the INTEREST trial, it appears likely that corticosteroid use diminished the treatment benefit of Traumakine in ARDS patients in the Japanese Phase III study. Unfortunately, the use of steroids has become a standard in ARDS despite any evidence base and this requires critical reassessment, as the use of steroids appears to worsen outcomes in certain ARDS subgroups.\"\n \n \nThe information contained within this announcement constitutes inside information stipulated under the Market Abuse Regulation (EU) No. 596/2014.\n \n \nFor more information please contact:\n \nFaron Pharmaceuticals Ltd\nDr Markku Jalkanen, Chief Executive Officer\[email protected] \n \nConsilium Strategic Communications\nMary-Jane Elliott...