Spectral Medical and partner Vantive are ploughing ahead with an application for the approval of their endotoxic septic shock therapy after it exceeded expectations in a Phase III trial.
In topline results from the TIGRIS trial (NCT03901807), its Polymyxin B Hemoadsorption (PMX) cartridge, toraymyxin, met the primary endpoint of day 28 mortality with a posterior probability of benefit of 95.3% – just exceeding the 95% target set by Spectral.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Toraymyxin is a haemoperfusion device that removes endotoxin, a toxic substance produced by bacteria, from blood.
In the trial, in patients with endotoxic septic shock, 28-day mortality after treatment with PMX was 38.7% compared to 45.1% with standard of care (SoC), a 6.4% absolute difference.
The 90-day data were even stronger, with a more than 99% probability of benefit in patients treated with PMX. Observed mortality at 90 days was 43.4% in patients who received PMX compared to 60.8% with SoC, a 17.4% difference.
Full results from TIGRIS will be submitted for presentation at an upcoming major medical conference and for publication in a peer-reviewed journal later in 2025.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataThe device was first approved in Europe more than 20 years ago in 1994 by Toray Industries, and in Japan in 2002. Spectral Medical gained US rights for the technology from Japan-headquartered Toray Industries in 2009.
Spectral Medical intends to submit the final Premarket Approval module for PMX to the US Food and Drug Administration (FDA) by the end of October 2025.
In July 2022, the FDA granted Breakthrough Device Designation for PMX for the treatment of endotoxic septic shock.
If approved in the US, the device will be distributed by Vantive, which also has non-exclusive rights to distribute Endotoxin Activity Assay (EAA), an FDA-approved rapid test that measures endotoxin activity.
While enrolling its own patients, the TIGRIS trial model also incorporated data from 179 patients who were evaluated in the EUPHRATES trial (NCT01046669), which investigated the therapy in patients with septic shock and endotoxemia. The trial was delayed in November 2024 due to Hurricane Helene impacting medical supply chains.
The device was also investigated in the EUPHAS trial 16 years ago, said Professor Claudio Ronco, Director of the International Renal Research Institute of Vicenza IRRIV.
“Like in EUPHAS, patients in the Tigris trial have a 28-day mortality of approximately 50% unless treated with PMX,” Ronco said. “The benefit for survival from PMX becomes even more dramatic at 90 days, where it exceeds 17%. This is not unexpected as today many patients can be maintained on life support for more than 28 days – as such, longer term survival is a more accurate reflection of benefit.”
Each year, there are around five to seven million cases of endotoxic septic shock that occur worldwide, but there is yet to be an approved treatment specifically targeting the condition in the US. Currently, patients receive therapy and vasopressor medications, such as norepinephrine, to raise blood pressure and provide better blood flow to organs.
