Faron Pharmaceuticals Ltd ("Faron") (AIM: FARN), announced on 5/8/17 top line data from its pan-European Phase III INTEREST trial. The INTEREST study did not meet the Day 28 (D28) primary efficacy composite endpoint of ventilator free days and survival with Traumakine treatment. Traumakine was being studied for treatment of acute respiratory distress syndrome (ARDS).

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.

 
Safety was continually monitored throughout the study and there were no clinical concerns following the repeated administration of Traumakine.

Acute respiratory distress syndrome (ARDS) occurs when fluid builds up in the tiny, elastic air sacs (alveoli) in the lungs. The fluid prevents lungs from filling with enough air, which means less oxygen reaches the bloodstream. This deprives organs of the oxygen they need to function. ARDS is estimated to affect approximately 200,000 in the US each year.

Faron Shares had fallen over 85% as of this writing.