Tigris Trial Update: Spectral Medical's February Enrollment Progress

Spectral Medical Inc., a company in the final stages of development aiming to secure U.S. FDA approval for its sepsis and septic shock treatment, has provided an update on its ongoing Tigris trial. The Phase 3 study is assessing the efficacy of Polymyxin B Hemoperfusion (PMX) in treating adults with endotoxemia and septic shock. The trial has seen a strong enrollment trend, with 88 patients already enrolled, marking January as the most successful month for recruitment since the study began. The company is nearing its interim target of 90 patients, a milestone that could trigger a second payment from Baxter to Spectral, securing Baxter's exclusive distribution rights for PMX.

The Tigris trial has also made progress in expanding its clinical sites, with the University of Texas Health Sciences Center at Houston recently finalizing its participation in the study. Spectral anticipates further site onboarding in the first quarter of 2024, with training at four sites already scheduled for February.

Spectral's CEO, Chris Seto, highlighted the significance of the enrollment progress, stating that reaching the 90-patient milestone could be a turning point for the company. With only 62 patients remaining to reach full enrollment, the company is gearing up for the final phase of the Tigris trial.

Spectral's flagship product, Toraymyxin™ (PMX), is a therapeutic device designed to remove endotoxin from the bloodstream, which can lead to sepsis. The device is already approved for use in Japan and Europe and has been safely and effectively used in over 340,000 patients. In 2022, the U.S. FDA granted Breakthrough Device Designation for PMX in treating endotoxic septic shock, a severe form of sepsis.

The Tigris Trial is a pivotal study comparing PMX in conjunction with standard care against standard care alone, utilizing Bayesian statistics and a 2:1 randomization of 150 patients. The study's methodology is outlined in "Bayesian methods: a potential path forward for sepsis trials."