Traumakine fails Phase III INTEREST trial for ARDS.- Faron Pharma.
Faron Pharmaceuticals Ltd the clinical stage biopharmaceutical company, announces top line data from its pan-European Phase III INTEREST trial of Traumakine in the treatment of ARDS ( Acute Respiratory Distress Syndrome). The INTEREST study did not meet the Day 28 (D28) primary efficacy composite endpoint of ventilator free days and survival with Traumakine treatment. Treatment with Traumakine did not result in an increased number of ventilator free survival days or a reduced mortality rate when compared to placebo.
The median number of ventilator free days at Day 28 was 10 days in patients treated with Traumakine and 8.5 days in the placebo group. � All cause mortality at Day 28, another important efficacy endpoint, was 26.4% for Traumakine and 23.0% for the placebo group.� At Day 90 all cause mortality in the Traumakine group was 32.6% compared to 31.6% in the placebo group.� None of these differences were statistically significant.