Spectral Medical Inc. (TSX: EDT) is making significant strides in its Tigris trial, a Phase 3 study assessing Polymyxin B Hemoperfusion (PMX) for treating endotoxemia and septic shock in adults. The trial is on track to be completed soon, potentially offering a new therapeutic option for a critical condition.
Tigris Trial Enrollment Update
As of early February 2025, the Tigris trial has enrolled 146 patients. Enrollment saw a strong close to 2024, with 59 patients enrolled during the year, compared to 31 in 2023. December 2024 experienced improved enrollment rates as issues related to the production of critical intravenous fluids began to ease. The company projects full enrollment of 150 patients closer to the end of the first quarter of 2025.
Chris Seto, Chief Executive Officer of Spectral Medical, noted, "Our enrollment throughout 2024 was incredibly robust – even when taking into account the enrollment disruptions encountered throughout the fourth quarter," indicating confidence in meeting enrollment targets.
Polymyxin B Hemoperfusion (PMX)
PMX is a therapeutic hemoperfusion device designed to remove endotoxin from the bloodstream, addressing a key factor in 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, with over 340,000 patients treated to date.
Regulatory and Commercialization
In July 2022, the U.S. FDA granted Breakthrough Device Designation for PMX in treating endotoxic septic shock, which affects approximately 330,000 patients annually in North America. The Tigris trial is designed as a 2:1 randomized study of 150 patients using Bayesian statistics to confirm PMX's efficacy when added to standard care, compared to standard care alone.
Dr. John Kellum, Chief Medical Officer of Spectral, stated, "We view December as a transitional month from an enrollment perspective, as the medical supply chain issues eased. Given the continued strong engagement and enthusiasm at our Tigris sites, we anticipate a return to a more normalized enrollment rate in the new year."
About Spectral Medical Inc.
Spectral Medical Inc. is a Phase 3 company focused on gaining U.S. FDA approval for Toraymyxin™ (PMX) for septic shock treatment. The Tigris trial is a confirmatory study of PMX combined with standard care versus standard care alone, employing a 2:1 randomized design with 150 patients, utilizing Bayesian statistics. Spectral is listed on the Toronto Stock Exchange under the symbol EDT.
