Faron Pharmaceuticals Oy (LON:FARN) is mulling its next steps after receiving interim results from the INFORAAA trial of its interferon-beta drug Traumakine.
The company has announced the interim results from the Phase II INFORAAA study, which examined the effect of Traumakine on mortality and pharmacodynamic (the biochemical and physiological effects of drugs) biomarkers of surgically-operated ruptured abdominal aorta aneurysm patients.
Faron said analysis of the interim results supported the continuation of the study.
Traumakine treatment during the INFORAAA trial was identical to the INTEREST trial (a phase III clinical trial on patients with acute respiratory distress syndrome), Faron said.
A total of 35 patients were included in the interim read-out, 25 of which were treated with Traumakine and 10 of which received a placebo.
Faron said the responses from the MxA and CD73 biological markers (biomarkers) indicated a good interferon response. Unexpectedly, at the same time, corticosterone was recorded both in the active (28%) and placebo (30%) treatment arm.
The measurement of CD73 serum concentrations indicated that this concomitant corticosteroid use negated a CD73 response, as observed earlier in all three previous studies - two independent phase III and the company's own YODA study that was instigated to find out why Traumakine did not perform as expected in the INTEREST trial.
Patients without Traumakine-induced CD73 values were more likely to die than those with induction, Faron said. The corticosteroid-treated patients from statistical analysis reduced group sizes and made statistical mortality analysis meaningless, but a trend toward reduction of mortality was seen in the Traumakine-treated patients who did not receive corticosteroids.
Mortality in various groups varied from 15-20%, except in those patients without induced CD73 concentrations - mortality in that group was high with six out of seven not surviving.
The company said it would evaluate the interim results in conjunction with previously announced data from the YODA trial and post-hoc INTEREST data to finalise its plans for future Traumakine development and will make further announcements in due course.
"The INFORAAA interim data is very important to us as it again shows the protective effects of CD73 activation without the presence of steroids,” said Dr Markku Jalkanen, the chief executive officer of Faron.
“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,” he added.
“It was disappointing to learn about this magnitude of steroid use in this patient population as RAAA [ruptured abdominal aorta aneurysm patients] is considered as a traumatic condition and to have only limited inflammatory impact on disease development," the CEO concluded.