Spectral Medical Inc. (TSX: EDT) is advancing its Phase 3 Tigris trial, a study assessing Polymyxin B Hemoperfusion (PMX) in adults with endotoxemia and septic shock. The trial has reached 82 enrolled patients, demonstrating accelerated screening activity with over 100 patients screened weekly across trial sites.
The Tigris trial is designed as a 2:1 randomized controlled trial involving 150 patients, employing Bayesian statistics to evaluate PMX combined with standard care versus standard care alone. The primary endpoint is 28-day mortality, with one-year mortality as a key secondary endpoint. The study population includes patients with septic shock who exhibit endotoxemia.
Enrollment and Interim Milestone
Enrollment for the Tigris trial has shown significant momentum, particularly after the holiday break, with sites actively screening and enrolling patients. The trial is nearing its interim enrollment target of 90 patients. Achieving this milestone would give Baxter International (NYSE:BAX) the option to make a second non-dilutive milestone payment to Spectral, securing its exclusive distribution rights for PMX.
Mortality Data and Clinical Outlook
According to Spectral Medical, preliminary crude mortality results at both 28 days and one year have exceeded pre-defined efficacy targets. These early data points are encouraging, suggesting a potential benefit of PMX in reducing mortality associated with septic shock. However, these are interim results and the final outcome will depend on the complete dataset from the fully enrolled trial.
Dr. John Kellum, Chief Medical Officer of Spectral, noted the robust enrollment activities and the progress in opening additional clinical sites. Chris Seto, Chief Executive Officer of Spectral Medical, expressed excitement about the company's prospects for 2024, highlighting the proximity to the interim enrollment milestone and the ongoing push to fully enroll the Tigris trial.
PMX and Endotoxemic Septic Shock
PMX is a therapeutic hemoperfusion device designed to remove endotoxin from the bloodstream, addressing a key factor in the pathogenesis of sepsis. It is guided by Spectral's Endotoxin Activity Assay (EAA), an FDA-cleared diagnostic tool for assessing the risk of developing sepsis. PMX is already approved for therapeutic use in Japan and Europe, where it has been used in over 340,000 patients.
Endotoxic septic shock, a severe form of sepsis, affects approximately 330,000 patients annually in North America. The Tigris trial aims to provide confirmatory evidence of PMX's efficacy in this critical condition, potentially offering a new treatment option for patients with septic shock.
