Spectral Medical enrolls 136 patients despite supply chain issues
- The Tigris trial enrolled 136 patients by the end of November 2024, focusing on patients with endotoxemia and septic shock.
- Hurricane Helene disrupted the saline supply, significantly impacting patient enrollment since October.
- Despite challenges, management remains optimistic about finalizing enrollment and advancing the trial.
In Canada, Spectral Medical Inc. announced an update regarding its Tigris trial on December 2, 2024. The trial, which is a Phase 3 study, focused on the efficacy of Polymyxin B Hemoperfusion for adults suffering from endotoxemia and septic shock. As of the end of November 2024, the company reported that 136 patients had been enrolled in the trial. However, patient enrollment was significantly impacted in October and November due to the repercussions of Hurricane Helene. The hurricane disrupted the medical supply chain, leading to a shortage of saline, which is essential for preparing PMX treatments. Each PMX treatment requires 5 liters of saline, and this shortage has constrained the availability of resources necessary for the trial. Despite these setbacks, Spectral Medical's management remains optimistic about the Tigris trial's progress. Dr. John Kellum, the Chief Medical Officer, noted that trial sites are actively engaged and enthusiastic about attracting additional participants as they strive towards finalizing enrollment. The company indicated that they are focused on mitigating the impacts of the supply chain issues and emphasized that the challenges faced in patient enrollment are believed to be temporary. The Tigris trial serves as a confirmatory study, aiming to compare the effectiveness of PMX in conjunction with standard care versus standard care alone in a randomized controlled setting. The Tigris trial's design includes a total of 150 patients, utilizing Bayesian statistics for evaluation. With approximately 330,000 patients diagnosed with septic shock annually in North America, the Tigris trial is crucial for confirming the therapeutic options available for this serious condition. As such, despite the hurdles posed by Hurricane Helene, the company aims to continue pushing forward to finalize enrollment within the shortest possible timelines. The commitment to the trial reflects a broader interest in advancing medical treatments for critical conditions like sepsis and highlights the ongoing implications of environmental events on healthcare operations.