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Faron stock falls on traumakine failure

July 09, 2018 By pharmatimes

ADRS is a severe orphan disease with a reported mortality rate of approximately 30-45 percent for which there is currently no approved pharmacological treatment.

It is characterised by widespread capillary leakage and inflammation in the lungs, most often as a result of pneumonia, sepsis, or significant trauma.

Top line data from the pan-European Phase III INTEREST trial show that the traumakine failed to meet the primary efficacy composite endpoint of ventilator free days and survival.

The median number of ventilator free days at Day 28 was 10 days in patients treated with the drug and 8.5 days in the placebo group, while all cause mortality at Day 28 was 26.4 percent and 23.0 percent, respectively.

On the safety side, there were no clinical concerns following the repeated administration of the drug, the firm noted.

"We are incredibly disappointed and surprised by these results,” said the firm’s chief executive Dr Markku Jalkanen.

“We need to further analyse the data in order to understand how this study differs from our previous positive results with ARDS patients, both in terms of Traumakine's efficacy, and in the unusually low mortality rate observed in the placebo arm.”

The firm said it would consider how its advances the drug after collecting results from an ongoing Japanese study in the third quarter of 2018.

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