Spectral Medical Inc. (TSX: EDT) is making significant strides in its Tigris trial, a Phase 3 study assessing Polymyxin B Hemoperfusion (PMX) for treating endotoxemia and septic shock. As of September 2024, the trial has enrolled 132 patients, marking a substantial increase in enrollment compared to the previous year.
The Tigris trial is a randomized controlled study evaluating PMX in adults with endotoxemia and septic shock. The trial employs a 2:1 randomization, aiming to enroll a total of 150 patients, utilizing Bayesian statistics for analysis. This confirmatory trial seeks to validate the efficacy of PMX when used in conjunction with standard care, compared to standard care alone.
Enrollment Update
The enrollment rate for the Tigris trial has shown significant improvement in 2024. So far, 51 patients have been enrolled this year, compared to 31 patients enrolled throughout 2023. With only 18 patients left to reach the target enrollment, Spectral Medical anticipates completing the Tigris trial around the end of 2024.
Dr. John Kellum, Chief Medical Officer of Spectral, expressed confidence in the trial's progress, stating, "We continue to enjoy very strong activity at our sites. As such, we remain confident in finalizing full Tigris enrollment around year end 2024."
About PMX and Spectral Medical
Spectral Medical is a late-stage theranostic company focused on developing therapeutic options for sepsis and septic shock. Their primary product, Toraymyxin™ (PMX), is a hemoperfusion device designed to remove endotoxin from the bloodstream, addressing a key factor in the development of sepsis. The company's Endotoxin Activity Assay (EAA™) is the only FDA-cleared diagnostic 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. In the United States, the FDA granted Breakthrough Device Designation for PMX in July 2022, specifically for treating endotoxic septic shock. Approximately 330,000 patients are diagnosed with septic shock in North America annually, highlighting the significant unmet medical need.
Vantive-Carlyle Group Transaction
Management also provided their view on the recently announced Vantive-Carlyle Group transaction. On August 13, 2024, Baxter International announced that it had reached a definitive agreement with The Carlyle Group to divest its Vantive business. Spectral Medical’s PMX distribution agreement with Baxter will be assigned to Vantive upon closing of the Vantive-Carlyle transaction, which is expected to close in late 2024 or early 2025. Chris Seto, Chief Executive Officer of Spectral, commented, “We believe the Vantive-Carlyle transaction is an overwhelmingly positive event for Spectral. The Carlyle Group has been a leading private equity investor in the medical technology sector, with investments totaling over $40 billion in enterprise value. Ultimately, with the change in ownership to The Carlyle Group, Vantive should be in a strong financial position to support and drive the commercialization effort of EAA and PMX.”
