Spectral Medical Inc. (TSX: EDT) announced an update on its Tigris trial, a Phase 3 study assessing Polymyxin B Hemoperfusion (PMX) for adults with endotoxemia and septic shock. The trial has reached 135 enrolled patients by the end of October 2024, signaling significant progress toward completion.
Enrollment Momentum in Tigris Trial
The Tigris trial has demonstrated strong enrollment figures in 2024, with 54 patients recruited so far, compared to 31 in all of 2023. With only 15 patients remaining to reach the target enrollment of 150, Spectral Medical is in the final phase of the trial. Management estimates that the Tigris trial will be completed around the end of 2024, based on the current enrollment rate.
Dr. John Kellum, Chief Medical Officer of Spectral, acknowledged a slight dip in the October enrollment rate but emphasized the continued strong screening performance across trial sites. He noted the eagerness of the sites to complete the Tigris trial while ensuring the appropriate patient selection.
About PMX and Spectral Medical
Spectral Medical is pursuing U.S. FDA approval for Toraymyxin™ (PMX), a therapeutic hemoperfusion device designed to remove endotoxin from the bloodstream, a key factor in sepsis. PMX is guided by the company’s Endotoxin Activity Assay (EAA™), the only FDA-cleared diagnostic for assessing the risk of developing sepsis.
PMX has already been approved for therapeutic use in Japan and Europe, where it has been safely and effectively used in over 340,000 patients. Spectral Medical holds exclusive development and commercial rights for PMX in the U.S. since March 2009 and has an exclusive distribution agreement for Canada since November 2010. The U.S. FDA granted Breakthrough Device Designation for PMX in July 2022 for treating endotoxic septic shock, a condition affecting approximately 330,000 patients annually in North America.
The Tigris trial is designed as a 2:1 randomized trial involving 150 patients, comparing PMX plus standard care to standard care alone, using Bayesian statistics. The trial aims to confirm the efficacy of PMX in treating endotoxic septic shock, a severe form of sepsis.
