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(Alliance News) - Faron Pharmaceuticals Oy on Wednesday said interim results from its phase two Inforaaa study support continuation but the study is limited by a lack of patients not also taking corticosteroids.
Shares in Faron were down 14% at 115.20 pence in late morning trade.
The study is intended to analyse the effect of Traumakine on mortality and biomarkers in patients who had undergone surgery following a ruptured abdominal aorta aneurysm.
Overall, 35 patients were included in the interim read out, of which 25 had been treated with Traumakine and 10 with placebo. Biomarkers suggested a good response.
However, corticosteroid use was "unexpectedly" reported in 28% of patients taking Traumakine and 30% of patients in the placebo arm. Measuring the concentration of the biomarker CD73, moreover, showed that using corticosteroids while taking Traumakine "abolished a CD73 response".
The ability of steroids to reduce biomarker response in Traumakine patients has been observed in other testing, including Faron's Yoda trial in healthy volunteers.
Those patients involved in the study whose CD73 values were not induced by Traumakine had a higher likelihood of death and a reduction in mortality was observed in patients who took the drug and were not taking corticosteroids.
Nonetheless, "the removal of corticosteroid-treated patients from statistical analysis reduced group sizes and made statistical mortality analysis meaningless".
The study may proceed, based on the criteria determined before the study and based on statistical analysis of mortality. Faron will look at this data, as well as that from its Yoda trial, to decide on its future plans.
"The Inforaaa interim data is very important to us as it again shows the protective effects of CD73 activation without the presence of steroids. It is still too early to estimate the efficacy of Traumakine in this setting because of the limited number of evaluable patients without concomitant steroids, however the interim analysis supports the continuation of the study according to current powering. It was disappointing to learn about this magnitude of steroid use in this patient population as [ruptured abdominal aorta aneurysm] is considered as a traumatic condition and to have only limited inflammatory impact on disease development," said Faron Chief Executive Markku Jalkanen.
