Faron Pharmaceuticals has said that clinical results from a study for the treatment of acute respiratory distress syndrome (ARDS) showed that the use of steroids appeared to worsen outcomes in several patients.
The company noted that treatment with Traumakine did not result in reduced mortality or an increased number of ventilator-free survival days when compared to placebo.
The placebo and Traumakine treatment groups were reported to be 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.
Faron said the post-hoc analysis revealed that 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 demonstrated the same trends to that observed from the Interest study.
Additional sub-group analysis is not meaningful because of the limited trial size.
Faron Pharmaceuticals CEO Markku Jalkanen 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.”
Traumakine is currently under clinical investigations in ARDS and for the prevention of multi-organ failure after emergency aortic surgery.
ARDS is a serious, life-threatening medical condition characterised by widespread inflammation in the lungs and sudden failure of the respiratory system.
The UK’s Medicines and Healthcare Products Regulatory Agency has granted Promising Innovative Medicines designation for Traumakine, which is based on a patent-protected use of intra-venous interferon beta to prevent capillary leakage in organs under threat of ischemia and inflammation.