TORONTO - Spectral Medical Inc. (TSX:EDT), a company specializing in therapies for sepsis and septic shock, is nearing an important milestone in its Tigris trial, a Phase 3 study evaluating the Polymyxin B Hemoperfusion (PMX) device. The trial, which commenced in 2024, has recently accelerated its patient enrollment, with the company announcing that it has screened over 100 patients per week post-holiday season and has enrolled patient number 82 in the first week of January.
The Tigris trial aims to assess the efficacy of PMX in treating adults with endotoxemia and septic shock. Spectral Medical reported that the preliminary mortality data at both the 28-day primary endpoint and at one year have so far exceeded the efficacy targets set for the study.
With the interim enrollment target of 90 patients approaching, Spectral Medical is on the verge of receiving the second non-dilutive milestone payment from Baxter International (NYSE:BAX), which maintains exclusive distribution rights for PMX. This payment is contingent upon reaching the interim enrollment target.
The company is also expanding its trial sites, with six new high-quality clinical sites expected to be onboarded in the near future. This expansion is anticipated to significantly increase the pace of enrollment during the first quarter of 2024.
Dr. John Kellum, Chief Medical Officer of Spectral, expressed optimism about the trial's progress, attributing the strong enrollment to the resumption of robust activities at clinical sites following the holiday break. Chris Seto, CEO of Spectral Medical, echoed this sentiment, stating that the company is excited about the prospects for 2024 and is focused on the final push to fully enroll and complete the Tigris trial.
Spectral Medical's PMX device is designed to remove endotoxin, which can cause sepsis, from the bloodstream. It is currently approved for therapeutic use in Japan and Europe and has been used on over 340,000 patients. In the United States, PMX has been granted Breakthrough Device Designation by the FDA for the treatment of endotoxic septic shock.
The Tigris Trial is being conducted as a 2:1 randomized trial of 150 patients, using Bayesian statistics to compare the efficacy of PMX in addition to standard care versus standard care alone.
The information in this article is based on a press release statement.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.