Topline results from the Tigris trial have just been announced.
This phase 3 follow-on sponsored study evaluates the use of Polymyxin B Hemoadsorption (“PMX” – Toray Medical Inc, Tokyo) in a randomized clinical trial of adults treated for Endotoxic Septic Shock (ESS) selected using the Endotoxin Activity Assay (EAA – Spectral Medical Inc., Toronto)
Specifically, the Tigris trial was a U.S.-based, multicenter, randomized, controlled Phase 3 study evaluating PMX in adults with endotoxic septic shock, defined with EAA level between 0.60 and 0.90.
Eligible patients also had to meet criteria for multiple organ dysfunction, including a Multiple Organ Dysfunction Score (“MODS”) > 9 or a Sequential Organ Failure Assessment (“SOFA”) score of >11.
A total of 157 patients were randomized in a 2:1 ratio to receive either PMX plus standard care (n=106) or standard care alone (n=51)
PMX achieved the primary and key secondary endpoints, showing:
👉 28 days Pooled absolute risk reduction of 8.3% and a relative risk reduction of 18% compared to standard of care.
👉 90-day Mortality 17.4% lower compared to standard of care and >99% posterior probability of benefit.
👉 38.7% Mortality at 28 days with PMX (with 45.1% mortality in the standard of care group) confirms the results of the prior trial subset.
For many years, PMX has represented the reference blood purification therapy in the management of Endotoxic Septic Shock and has been adopted in many countries in Asia and Europe with more than 360,000 treatments performed.
While waiting to read the full publication of the study, these results represent a milestone in the adjunctive therapies for managing septic shock as well as in the Blood Purification field.
The TIGRIS trial was conceived to continue with the pathway, with the FDA aiming to obtain authorization to introduce PMX in clinics in the US for the management of endotoxic septic shock.
Read the press release from Spectral Medical here.