Spectral study defines deadliest septic shock group

Executive Summary

• Spectral Medical announced the publication of the "Eden" observational study in Critical Care Explorations, which defines Endotoxic Septic Shock (ESS) as a distinct, high-mortality subtype of septic shock.
• The study found that patients with ESS (defined by EAA ≥ 0.6 and specific organ failure scores) had a 28-day mortality rate of 57.1%, compared to 15.9% for other septic shock patients, representing a more than threefold increase in death risk.
• The findings provide clinical validation for Spectral’s theranostic strategy (pairing the EAA diagnostic with the PMX hemoadsorption device) and align with enrollment criteria for the company's recently completed Tigris trial, strengthening the evidence base for an upcoming FDA submission.

Key Details

• Study Findings: The prospective, multicentre observational study included 90 patients.
• ESS Definition: Endotoxin Activity Assay (EAA) ≥ 0.6 combined with either a Multiple Organ Dysfunction Score (MODS) > 9 or a Sequential Organ Failure Assessment (SOFA) > 11.
• Mortality Rates:
  • ESS patients: 57.1% 28-day mortality.
  • Other septic shock patients: 15.9% 28-day mortality.
• Strategic Alignment: The criteria used to define ESS in the Eden study directly align with the enrollment parameters of Spectral’s recently completed Tigris trial (a 2:1 randomized trial of 150 patients using Bayesian statistics).
• Regulatory Context: The publication supports the evidence base for Spectral’s upcoming FDA submission for PMX (Toraymyxin) in the United States. PMX received Breakthrough Device Designation from the U.S. FDA in July 2022.
• Product Status: PMX is approved in Japan and Europe, licensed by Health Canada, and has seen over 360,000 units sold worldwide. Spectral holds exclusive U.S. development and commercial rights.

Notable Quotes

• "These findings underscore that endotoxin activity, when combined with measures of organ failure, identifies the sickest sepsis patients with the greatest likelihood of dying," said Dr. John Kellum, chief medical officer at Spectral Medial. "By precisely identifying this high-risk subgroup, we can better design clinical trials and target therapies, such as endotoxin removal, to the patients most likely to benefit."