Spectral Announces Publication of the post hoc analysis of EUPHRATES trial in Intensive Care Medicine

Spectral Medical (TSX:EDT), a Phase III company developing the first treatment for patients with endotoxemic septic shock guided by a companion diagnostic, today announces that a new paper reporting on the population that had a clinically important mortality benefit and other physiologic benefits from PMX within the EUPHRATES trial titled: “Polymyxin B hemoperfusion in endotoxemic septic shock patients without extreme endotoxemia: a post hoc analysis of the EUPHRATES trial” was published in Intensive Care Medicine.

As quoted in the press release:

As previously disclosed, the EUPHRATES trial failed to show a statistically significant PMX related survival benefit in the Intention to Treat [all subjects who were randomized] and per protocol [all patients who received two full treatments or full sham event] populations. However, the post hoc analysis revealed there is a population of patients with a high severity of illness (MOD score > 9) and an EAA between 0.6 and 0.89, that showed PMX use is associated with an absolute mortality benefit over sham patients of 10.7% at 28 days. This group of patients also showed improvement in organ function with fewer days relying on mechanical ventilation and renal support in the PMX treated group.

“We have maintained our commitment to learn as much as possible from the EUPHRATES trial database. We have submitted these findings to FDA and are now in discussion with them as to a study design that will allow further efficacy and safety data to be collected on this group of patients; the TIGRIS trial,” said Dr. Paul M Walker, CEO of Spectral.

Click here to read the full press release.