Spectral Medical Achieves Positive Outcomes in Clinical Trial of PMX to Treat Life-Threatening Endotoxemic Septic Shock

Spectral Medical Inc., a theranostic company focused on advancing therapeutic options for sepsis and septic shock, has recently announced positive results from EUPHAS-2, an observational study in Italy.

The study used EAA-guided PMX hemoadsorption to treat patients with endotoxemic septic shock, and the results have been featured in Artificial Organs, a leading journal for organ replacement therapies and organ machine perfusion preservation. This is a major breakthrough for Spectral, as the results suggest improved outcomes for sepsis and septic shock patients.

A study of 50 patients suffering from septic shock and endotoxin activity (EAT0) ≥ 0.6 was conducted to examine the effectiveness of Polymyxin-B hemoadsorption (PMX) therapy. The primary outcomes of the study included the endotoxin activity (EA) score using Spectral’s Endotoxin Activity Assay (EAA™) and the Sequential Organ Failure Assessment (SOFA) score progression over 120 hours. The results of the study will help to determine the efficacy of PMX therapy in treating septic shock.

Septic shock is a serious condition that can be caused by abdominal or pulmonary infections. In a recent study, abdominal infections were the most common cause of septic shock, accounting for 54% of cases. Over the course of 120 hours, there was a marked improvement in patients’ health, as indicated by a decrease in EA (p<0.001), an improvement in their SOFA score (p<0.001), and better hemodynamics (p<0.001).

The Simplified Acute Physiology Score II (SAPS II) predicted a 28-day mortality rate of 75%, however, among patients who received PMX the 28-day mortality rate was significantly lower at 36%. Furthermore, patients whose high EA resolved within 48 hours were less likely to progress to kidney failure compared with those with EAT48≥0.6. This highlights the importance of early PMX in reducing mortality and preventing kidney failure.

Dr. John Kellum, Chief Medical Officer of Spectral Medical, was thrilled to discover that a cohort of critically ill patients with high EAA and severity of illness achieved an impressive 64% survival rate with PMX therapy.

The EUPHAS-2 study also showed that those with decreasing EAA responded faster to recovery from septic shock. To further explore the potential of PMX therapy, Spectral Medical is currently conducting a prospective study comparing it to the standard of care in patients with similar disease severity and EAA levels as those enrolled in EUPHAS-2.

Spectral Medical’s CEO, Chris Seto, is thrilled to report encouraging trial results, which have been published in a respected, peer-reviewed journal. The data suggests that PMX therapy, which is currently being tested in the Tigris trial, is able to reduce endotoxin activity in patients with septic shock and high levels of endotoxemia.

This leads to improved organ function, better hemodynamics and fewer cases of kidney failure requiring renal replacement therapy. Furthermore, the preliminary Tigris mortality data has exceeded expectations. Spectral Medical is making great progress in the trial and is on track to reach its 150 patient target, bringing them closer to FDA submission and potential approval.

About Spectral

Spectral is a Phase 3 company on a mission to revolutionize the treatment of patients with septic shock. Their unique product, Toraymyxin™ (“PMX”), is a therapeutic hemoperfusion device that removes endotoxin, the cause of sepsis, from the bloodstream.

PMX is backed by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis. If approved, PMX could be a life-saving breakthrough for patients suffering from septic shock.

Spectral has been providing safe and effective therapy to over 340,000 patients around the world using its innovative product, PMX. After obtaining the exclusive development and commercial rights in the U.S. in 2009, the company followed up with signing an exclusive distribution agreement for PMX in Canada in 2010. Most recently, the U.S. FDA granted Breakthrough Device Designation for PMX to treat endotoxemic septic shock, a condition affecting 330,000 people in North America annually.

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