Business
Recruitment completed in Traumakine INTEREST Trial
Recruitment completed in Traumakine INTEREST Trial.
About this update from Faron Pharmaceuticals Oy
[{"type":"text","content":"\n \nRNS Number : 9280Y Faron Pharmaceuticals Oy 11 December 2017 \n\nFaron Pharmaceuticals Ltd\n(\"Faron\" or the \"Company\")\n \nRecruitment completed in Traumakine INTEREST Trial\n \nThe upcoming read-out will collate intact 90 day morbidity/mortality data alongside 28 day mortality data as requested by the study IDMC\n \nPhase III INTEREST top line results expected in H1 2018\n \nTURKU - FINLAND, 11 December 2017 - Faron Pharmaceuticals Ltd (\"Faron\") (AIM: FARN), the clinical stage biopharmaceutical company, announces that it has completed recruitment, on track, for its Phase III INTEREST trial of Traumakine® for the treatment of moderate to severe Acute Respiratory Distress Syndrome (ARDS). \n \nIn addition to the completion of recruitment, the Company reports that it has adopted recommendations from the INTEREST trial's Independent Data Monitoring Committee (IDMC) and Steering Committee (SC) to present patient data showing blinded ARDS outcomes (mortality/morbidity) at 90 days (D90), in addition to the day 28 (D28) mortality endpoint. Outcomes at D90 are widely recognised to be as important clinically when judging the benefit of treatment alongside the D28 data. This recommendation was made following the FDA's recent proposal for Faron to proceed directly to BLA filing for Traumakine in the US using data obtained from the European and Japanese trials. The Company expects therefore that the INTEREST top-line data from the trial will become available in H1 2018 following collation of the D90 data. Faron's Japanese partner Maruishi also expects Japanese phase III results in 2018. \n \nThe INTEREST trial is a Phase III double-blind, randomised, parallel-group comparison of efficacy and safety of Traumakine (FP-1201-lyo) and placebo in the treatment of patients with moderate to severe ARDS. The study, which has successfully recruited its target of 300 patients, is currently being conducted in more than 60 hospital intensive care units (ICU) in Belgium, Finland, France, Germany, Italy, Spain, UK and Czech Republic. The key efficacy endpoint in the INTEREST trial is the all-cause mortality rate at day 28. The INTEREST trial protocol is targeting a 50% reduction in all cause mortality at day 28 between placebo and treatment arm (from 30% down to 15%).\n \nARDS is a severe orphan di...