Patient 82 Enrolled in Spectral's Phase 3 Tigris FDA Trial for Septic Shock

Spectral Medical Inc., a company in the final stages of development aiming to secure FDA approval for its sepsis and septic shock treatment, has reported significant progress in its Phase 3 Tigris trial. The trial is designed to evaluate the effectiveness of Polymyxin B Hemoperfusion (PMX) in treating endotoxemia and septic shock in adults. The company began enrolling patients in 2024 and has already enrolled 82 patients in the first week of January, with screening activity surpassing 100 patients weekly.

Spectral is rapidly approaching its interim enrollment target of 90 patients, a milestone that, if reached, will trigger a second non-dilutive milestone payment from Baxter International to maintain its exclusive distribution rights for PMX. The preliminary crude mortality results at 28 days and one year have been promising, exceeding the set efficacy targets.

The company is also gearing up to onboard six new clinical sites in the near future and anticipates a significant increase in site onboarding activity during the first quarter of 2024. Dr. John Kellum, Spectral's Chief Medical Officer, expressed satisfaction with the robust enrollment activities and the progress made in opening additional sites, which is expected to accelerate the pace of enrollment.

Chris Seto, CEO of Spectral Medical, highlighted the company's excitement for 2024, stating that the strong start to the year brings Spectral close to its interim enrollment milestone. With 68 patients remaining to be enrolled, the company is in the final stages of completing the Tigris trial.

Spectral's PMX is a therapeutic hemoperfusion device that removes endotoxin from the bloodstream, a substance that can lead to sepsis. The device is guided by the company's Endotoxin Activity Assay (EAA™), an FDA-cleared diagnostic tool for assessing the risk of developing sepsis. PMX has already been approved for therapeutic use in Japan and Europe and has been safely and effectively used in over 340,000 patients. In 2009, Spectral obtained exclusive development and commercial rights for PMX in the U.S., and in 2022, the FDA granted Breakthrough Device Designation for PMX for treating endotoxic septic shock.

The Tigris Trial is a confirmatory study that compares PMX in addition to standard care against standard care alone. It is designed as a randomized trial of 150 patients using Bayesian statistics. Spectral is listed on the Toronto Stock Exchange under the symbol EDT. The company is committed to advancing its Tigris trial and is encouraged by the preliminary data that continues to exceed expectations.

The Tigris Trial is a crucial step towards securing FDA approval for Spectral's unique product, which could potentially benefit the approximately 330,000 patients diagnosed with septic shock in North America each year. The company's focus on robust enrollment and the onboarding of new clinical sites underscores its dedication to accelerating the development and approval process for its life-saving treatment.