Spectral Medical Inc. (TSX: EDT) announced an update on its Tigris Phase 3 trial, which is evaluating Polymyxin B Hemoperfusion (PMX) for endotoxemia and septic shock. The trial has enrolled 152 patients, nearing its target of 150 evaluable participants. The company expects to complete enrollment by the end of March 2025.
This near-completion of enrollment is a critical step for Spectral Medical. It allows the company to move closer to potential FDA approval for PMX, addressing a significant unmet need in the treatment of septic shock. Positive results could establish PMX as a valuable addition to the standard of care, potentially improving patient outcomes and reducing the burden of this life-threatening condition. This progress also strengthens Spectral’s position in the critical care market.
The Tigris trial is designed as a 2:1 randomized controlled trial employing Bayesian statistics. The company aims to enroll 100 patients in the PMX arm and 50 patients receiving standard care. This design is intended to provide robust data for regulatory review, specifically regarding safety and secondary analyses. The trial focuses on endotoxic septic shock, a severe form of sepsis. PMX is designed to remove endotoxin from the bloodstream, guided by Spectral’s Endotoxin Activity Assay (EAA™). PMX is already approved and used in Japan and Europe, with a history of safe use in over 340,000 patients.
The anticipated completion of Tigris trial enrollment marks a crucial juncture for Spectral Medical. It paves the way for data analysis and potential submission for regulatory approval, bringing the company closer to commercializing PMX in the U.S. and solidifying its position as a key player in sepsis treatment.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
