Spectral Medical and Vantive Announce Topline Results from Spectral’s Tigris Trial Evaluating PMX Hemoadsorption Therapy for Endotoxic Septic Shock

Core Insights - Spectral Medical Inc. and Vantive announced topline results from the Tigris trial, a Phase 3 study evaluating Polymyxin B Hemoadsorption (PMX) for treating endotoxic septic shock [1][2] Group 1: Trial Overview - The Tigris trial is a multicenter, randomized, controlled Phase 3 study conducted in the U.S. with 157 patients, comparing PMX plus standard care to standard care alone [2][3] - The primary endpoint was 28-day all-cause mortality, evaluated using a Bayesian statistical model that incorporated data from the previous EUPHRATES trial [3][4] Group 2: Key Findings - The trial exceeded the prespecified primary endpoint with a 95% posterior probability of benefit for PMX on 28-day mortality, showing an absolute risk reduction of 8.3% and a relative risk reduction of 18% [6][7] - The observed 28-day mortality was 38.7% for PMX compared to 45.1% for standard care, indicating a 6.4% absolute difference [7] - For the key secondary endpoint of 90-day mortality, PMX showed a 17.4% lower mortality rate with a >99% posterior probability of benefit [12] Group 3: Expert Commentary - Dr. John Kellum, Chief Medical Officer of Spectral, expressed satisfaction with the results, noting that the observed 6.4% difference exceeded the threshold established in prior simulations [9] - Professor Claudio Ronco highlighted the consistency of the Tigris results with earlier trials, emphasizing the effectiveness of PMX in selected patient populations [9] Group 4: Future Plans - Spectral Medical plans to submit the final Premarket Approval (PMA) module for PMX to the FDA by the end of October 2025, aiming to commercialize PMX and the Endotoxin Activity Assay (EAA) in the U.S. [9][10] - Vantive, as the exclusive distributor of PMX in the U.S. and Canada, is committed to advancing therapy innovation for critically ill patients [9][19]