Spectral Medical Inc. is making strides in its Tigris trial, a study evaluating the efficacy of Polymyxin B Hemoperfusion (PMX) in treating endotoxemia and septic shock. The trial aims to build upon data from the earlier EUPHRATES trial, with the primary endpoint being a reduction in 28-day mortality in septic shock patients treated with the PMX hemoperfusion cartridge versus standard of care.
Tigris Trial Update
The Tigris trial has reached a significant milestone with 40 patients now randomized across 14 active clinical sites. A notable case study from the University of Michigan (U of M) highlighted the potential benefits of PMX. According to Dr. Kyle Gunnerson, Professor and Emergency Medicine Director at the Emergency Critical Care Center within the University of Michigan, the first randomized patient at U of M experienced rapid improvement and was discharged from the ICU sooner than anticipated, with full discharge from the hospital in under two weeks from admission.
Dr. John Kellum, Chief Medical Officer of Spectral, noted, "The clinical staff at U of M witnessed immediate improvement in the patient’s status following administration of PMX and the patient was able to transfer out of the intensive care unit (ICU) sooner than expected. We believe this positive patient outcome, and the fact that data thus far is exceeding expectations, reinforces our prior EUPHRATES trial data and our overall confidence in the efficacy of PMX in this patient population."
Addressing Unmet Needs in Septic Shock
Sepsis and septic shock represent a critical unmet medical need, with an estimated 120,000 patients suffering from endotoxemic septic shock each year and facing a mortality rate of approximately 50%. The U.S. market alone is estimated at $1.6 billion. Currently, there are no FDA-approved sepsis solutions available, making the development of effective treatments like PMX crucial.
Chris Seto, Chief Executive Officer of Spectral Medical, commented, "We are making significant progress with our Tigris confirmatory trial and are very encouraged by the data thus far. With no approved or cleared treatments on the market, we believe, if Tigris is successful, we can swiftly move towards FDA submission, which follows our recent Breakthrough Device designation granted by the FDA. With continued progression of the Tigris trial, our Breakthrough Device designation, as well as our executed commercial partnership with Baxter, we remain laser focused on our goal of bringing PMX to market."
About PMX and Spectral Medical
PMX, also known as Toraymyxin™, is a therapeutic hemoperfusion device designed to remove endotoxin from the bloodstream, addressing a key factor in the development of sepsis. It is already approved for use in Japan and Europe, with over 340,000 patients treated to date. Spectral Medical holds exclusive development and commercial rights for PMX in the U.S. and an exclusive distribution agreement in Canada. The FDA granted Breakthrough Device Designation for PMX in July 2022 for the treatment of endotoxemic septic shock.
