Spectral Medical Inc. has announced the achievement of a major milestone in its clinical development program, reaching the interim enrollment target of 90 patients in the TIGRIS trial. This Phase 3 study is evaluating Toraymyxin™ (PMX), a therapeutic hemoperfusion device, for the treatment of septic shock. The trial's progress triggers a contractual option for Baxter International, Spectral's distribution partner, to make a milestone payment, reinforcing their commitment to commercializing PMX.
The TIGRIS trial is designed as a 2:1 randomized controlled trial, aiming to enroll a total of 150 patients. It compares PMX in conjunction with standard care against standard care alone in patients with septic shock. The study utilizes Bayesian statistical methods, offering a potential path forward for sepsis trials, as detailed in published literature. Endotoxic septic shock, a severe form of sepsis, affects approximately 330,000 individuals in North America annually.
PMX Mechanism and Regulatory Status
PMX is designed to remove endotoxin from the bloodstream, a key mediator of sepsis. It is guided by Spectral's Endotoxin Activity Assay (EAA™), the only FDA-cleared diagnostic for assessing the risk of developing sepsis. PMX is already approved for therapeutic use in Japan and Europe, where it has been used safely and effectively in over 340,000 patients.
In July 2022, the U.S. FDA granted Breakthrough Device Designation to PMX for the treatment of endotoxic septic shock, highlighting the unmet need and potential of this therapy. The TIGRIS trial is a confirmatory study intended to support a U.S. FDA approval application.
Management Perspective
"Enrolling patient 90 represents a major milestone in many ways for Spectral as we continue to see acceleration across our Tigris trial sites and building confidence and momentum towards completing the trial," said Chris Seto, CEO of Spectral Medical. "We remain confident in the outcome of Tigris and our potential for FDA approval, and look forward to our continued partnership with Baxter to commercialize PMX and bring a new standard of care across ICUs in the United States."
