Spectral Medical Inc. (TSX: EDT) announced an update on its Tigris trial, a Phase 3 study assessing Polymyxin B Hemoperfusion (PMX) for treating endotoxemia and septic shock. As of November 2024, the trial has enrolled 136 patients.
Enrollment Update
The Tigris trial, designed as a 2:1 randomized controlled trial with 150 patients using Bayesian statistics, experienced a slowdown in patient enrollment during October and November. This was primarily due to the impact of Hurricane Helene on the medical supply chain, which caused a shortage of critical intravenous fluids, including saline, essential for preparing PMX treatments.
Dr. John Kellum, Chief Medical Officer of Spectral, acknowledged the challenges but emphasized the continued engagement and enthusiasm of the Tigris sites. "Despite the continued saline shortage impacting patient enrollment, our Tigris sites remain engaged and enthusiastic in driving towards finalizing enrollment, as we continue to see strong performance across trial sites for screening," he stated.
Impact of Supply Chain Disruptions
The shortage of saline, where 5L are required to prepare PMX for each treatment, has led to rationing and negatively impacted patient enrollment. Spectral believes these disruptions are temporary and projects full enrollment by the end of the first quarter of 2025.
Tigris Trial Design and PMX Therapy
The Tigris trial is evaluating PMX, a therapeutic hemoperfusion device designed to remove endotoxin from the bloodstream. Endotoxins can trigger sepsis, a severe condition with a high mortality rate. PMX 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 on over 340,000 patients. The U.S. FDA granted Breakthrough Device Designation for PMX in July 2022 for treating endotoxic septic shock. Approximately 330,000 patients are diagnosed with septic shock in North America annually.
Upcoming Update Call
Spectral Medical will host a Tigris Trial and Corporate Update call on December 16, 2024, featuring Chris Seto, Chief Executive Officer, and Dr. John Kellum. The call will include a question-and-answer session for interested participants.
About Spectral Medical
Spectral Medical Inc. is a Phase 3 company focused on gaining U.S. FDA approval for Toraymyxin™ (PMX) for septic shock treatment. PMX acts by removing endotoxin from the bloodstream, addressing a key driver of sepsis. The company's EAA™ is the only FDA-cleared diagnostic for assessing sepsis risk.
