Faron Pharmaceuticals’s CEO Markku Jalk said it was disappointing to learn about the magnitude of steroid use in the patient population as RAAA is considered as a traumatic condition and to have only limited inflammatory impact on disease development.
After the company examined the effect of Traumakine on mortality (predominantly for Multi-Organ Failure, MOF) and pharmacodynamic biomarkers of surgically operated Ruptured Abdominal Aorta Aneurysm (RAAA) patients, in a second phase study, Faron said that Traumakine treatment during the INFORAAA trial was identical to the INTEREST trial with treatment once a day for six days following surgical operation.
According to the press release Faron issued Wednesday, the ratio of the treatment arm versus placebo was two to one and mortality was assessed for a period of 30 days after surgery. RAAA patients suffer two cycles of a potential ischemic injury to the vascular endothelium: the first caused by the rupture of the aorta and the resulting hemodynamic and circulatory collapse, which is then followed by the cross-clamping and un-clamping of the aorta leading to reperfusion injury. These mechanisms contribute to hypoxia-induced inflammation and multi organ failure, which is the main cause of death within the first 5-10 days. The expected mortality is normally between 30-50% of all operated patients.
Based on the study’s predefined decision criteria and statistical analysis of mortality in the active and placebo treatment arms the study may proceed. The company said it will evaluate these data, together 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.
Dr Markku Jalkanen, Chief Executive Officer of Faron, said: “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.”