Spectral Medical Inc. is making significant strides in its Tigris trial, a Phase 3 study assessing the efficacy of Polymyxin B Hemoperfusion (PMX) in treating endotoxemia and septic shock. The trial has reached 135 enrolled patients by the end of October 2024, marking substantial progress toward the target enrollment of 150 patients.
Enrollment Update
The Tigris trial has demonstrated robust enrollment figures for 2024. To date, 54 patients have been enrolled, significantly surpassing the 31 patients enrolled throughout 2023. With only 15 patients remaining to reach full enrollment, Spectral Medical is in the final phase of the Tigris trial. Management estimates trial completion around the end of 2024, contingent on the current enrollment pace.
Insights from Leadership
Dr. John Kellum, Chief Medical Officer of Spectral, commented on the trial's progress, stating, "Despite a lower enrollment rate for October we continue to see strong performance across trial sites for screening. Our sites are eager to complete Tigris but cautious to enroll the right patients."
About PMX and the Tigris Trial
Toraymyxin™ (PMX) is Spectral Medical's primary product, a therapeutic hemoperfusion device designed to remove endotoxin from the bloodstream, addressing a key factor in sepsis. PMX is guided by the Endotoxin Activity Assay (EAA™), Spectral's FDA-cleared diagnostic tool for assessing the risk of developing sepsis. PMX has already been approved for therapeutic use in Japan and Europe, with over 340,000 patients treated safely and effectively.
The Tigris trial is a confirmatory study evaluating PMX in conjunction with standard care against standard care alone. The trial employs a 2:1 randomization of 150 patients, utilizing Bayesian statistics. Endotoxic septic shock represents a severe manifestation of sepsis, affecting approximately 330,000 patients annually in North America.
The trial methods are detailed in “Bayesian methods: a potential path forward for sepsis trials”.
