Spectral Medical and Vantive Announce Topline Results from Spectral’s Tigris Trial Evaluating PMX Hemoadsorption Therapy for Endotoxic Septic Shock
Spectral Medical Inc.- Results exceed prespecified primary endpoint of 95% posterior probability of benefit for PMX on 28-day mortality
- Pooled absolute risk reduction of 8.3%; Relative risk reduction of 18%
- Key secondary endpoint: 90-day Mortality 17.4% lower with PMX and >99% posterior probability of benefit
- 38.7% Mortality at 28 days with PMX confirms results of prior trial subset
TORONTO, Ontario and DEERFIELD, Ill., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, and Vantive, a vital organ therapy company committed to pursuing novel diagnostic and therapeutic options for organ failure, today announced topline results from the Tigris trial. This Phase 3 follow-on study sponsored by Spectral evaluated the use of Polymyxin B Hemoadsorption (“PMX”) in a randomized clinical trial of adults treated for endotoxic septic shock.
Each year, approximately 5-7 million cases of endotoxic septic shock, a particularly deadly form of sepsis, occur worldwide.1 Today, there is no specific therapy targeting this patient population currently available in the United States. The Tigris trial was a U.S.-based, multicenter, randomized, controlled Phase 3 study evaluating PMX in adults with endotoxic septic shock, defined by an Endotoxin Activity Assay (“EAA”) level between 0.60 and 0.90. EAA is an FDA approved, semiquantitative test for measurement of endotoxin activity, allowing for rapid measurements to obtain results in approximately 30 minutes. The treating physician can use these results to help inform timely therapeutic decisions. Eligible patients also had to meet criteria for multiple organ dysfunction, including a Multiple Organ Dysfunction Score (“MODS”) >9 or a Sequential Organ Failure Assessment (“SOFA”) score of >11. A total of 157 patients were randomized in a 2:1 ratio to receive either PMX plus standard care (n=106) or standard care alone (n=51).
The primary endpoint—28-day all-cause mortality—was evaluated using a prespecified Bayesian statistical model, which evaluates results in the context of prior probability. The model incorporated data from 179 patients in the previously conducted EUPHRATES trial alongside the data from the Tigris trial. The EUPHRATES trial was conducted in North America and examined the impact of PMX on mortality in patients with septic shock and endotoxemia. The goal of the Tigris trial was to confirm the benefit of PMX hemoadsorption in patients with endotoxic septic shock, defined by EAA 0.60 but < 0.90. The Tigris trial’s design and analysis plan were aligned with published FDA’s Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials.2
Key Findings of the Tigris Trial and Bayesian Analysis:
The purpose of Bayesian analysis is to update prior evidence with new trial data, producing a ‘posterior probability’ that reflects the most current and complete picture of the treatment effect. Results are presented for adjusted and unadjusted analyses. Consistent with expert recommendations and the FDA’s guidance on clinical trials, the adjusted analysis is used to account for baseline prognostic covariates such as severity of illness and comorbidities – which provides a more precise estimate of the true treatment effect. Unadjusted analyses do not account for these important differences.
Primary Endpoint (28-Day Mortality):
- Intention to treat cohort showed a posterior probability of benefit of 95.3% at 28 days
- Adjusted odds ratio 0.67 [0.39-1.08]
- Adjusted posterior probability of benefit from PMX at 28 days exceeds the prespecified 95% target and thus meets the prespecified primary endpoint.
- Observed 28-day mortality for Tigris was 38.7% with PMX vs 45.1% with standard of care – 6.4% absolute difference.
- Unadjusted absolute risk reduction from the posterior distribution was 8.3% [-2.1%, 19.7%] representing a 18% relative risk reduction, posterior probability 92.3%.
- Observed 28-day mortality from the modified intention to treat population (includes 100 PMX and 51 control patients receiving any assigned treatment) was 37.0% with PMX vs 45.1% with standard of care – 8.1% absolute difference.
Key Secondary Endpoint (90-Day Mortality):
- The key secondary endpoint, mortality at 90 days, showed a >99% posterior probability of benefit for PMX.
- Adjusted odds ratio 0.54 [0.32-0.87]
- Adjusted posterior probability of benefit from PMX at 90 days was 99.4%.
- Observed mortality at 90 days (Tigris alone): 43.4% with PMX vs. 60.8% with standard of care – 17.4% absolute difference.
- Unadjusted absolute risk reduction from the posterior distribution was 12.3% [0.76%, 23.7%] representing a 20.2% relative risk reduction, posterior probability 98.3%.
- Resultant number needed to treat (“NNT”) to save 1 life at 90 days is 8.1.
Dr. John Kellum, Chief Medical Officer of Spectral Medical, commented, “We are pleased to announce that the fully adjusted Bayesian analysis met our prespecified goal of >95% posterior probability of benefit for 28-day mortality. As we explained in our November 14, 2023 press release, our published simulations involving over 2,000 potential trial results found an observed absolute risk reduction for mortality in the range of 6 - 7% in Tigris would meet this bar. Final results from Tigris indicate that our observed 6.4% difference yields a 95.3% posterior probability and thus exceeds this threshold. Furthermore our 90 days results provide important confirmation that benefits with PMX are persistent.”
Professor Claudio Ronco, Director of the International Renal Research Institute of Vicenza IRRIV and world-renowned expert in blood purification for sepsis, commented, “The results that we see today are a clear confirmation of what we observed more than 16 years ago with the EUPHAS trial. Tigris, together with a subset of patients from EUPHRATES indicate that hemoadsorption therapy with PMX can be effective if we select the correct population. Like in EUPHAS, patients in the Tigris trial have a 28-day mortality of approximately 50% unless treated with PMX. The benefit for survival from PMX becomes even more dramatic at 90 days where it exceeds 17%. This is not unexpected as today many patients can be maintained on life support for more than 28 days – as such, longer term survival is a more accurate reflection of benefit.”
Dr. Danielle Davison, Professor of Anesthesiology and Critical Care Medicine and Director of the Intensive Care Unit, George Washington University, Washington, DC, commented, “Having participated in both EUPHRATES and Tigris, it is particularly satisfying to see these final results. We look forward to having this therapy available for our patients.”
“Vantive is committed to supporting clinical research to advance therapy innovation and expand access to care for critically ill patients,” said Professor Peter Rutherford, Head of Worldwide Medical at Vantive. “We are encouraged by these results, and look forward to continuing to work toward addressing unmet clinical needs and improving outcomes for patients affected by endotoxic septic shock.”
“The results from Tigris represent a significant milestone for Spectral as we continue advancing toward our goal of improving outcomes in endotoxic septic shock,” said Chris Seto, Chief Executive Officer of Spectral Medical. “When considered alongside prior evidence from the EUPHRATES trial and real-world global experience, the totality of data supporting PMX continues to strengthen. Importantly, the safety profile observed in Tigris was consistent with PMX’s historical use with over 360,000 units sold worldwide. These findings further support our planned FDA PMA submission and our efforts to make this therapy available to the patients who need it most.”
Vantive is Spectral's exclusive distributor of PMX in the U.S. and Canada and has non-exclusive rights to distribute EAA globally. Spectral Medical intends to submit the final Premarket Approval (“PMA”) module (Module 3) for PMX to the FDA by end of October 2025. If approved by the FDA, Vantive plans to commercialize both EAA and PMX, beginning in the United States, to support Targeted Rapid Endotoxin Adsorption (TREA) Therapy. TREA therapy brings precision medicine to sepsis, delivering rapid, decisive treatment for patients with endotoxic septic shock.
Full results from the Tigris trial will be submitted for presentation at an upcoming major medical conference and for publication in a peer-reviewed journal later this year.
Spectral Medical Tigris Trial Topline Results Call
Chris Seto, Chief Executive Officer, and Dr. John Kellum, Chief Medical Officer, will host the call followed by a question-and-answer session. All interested parties are invited to participate.
CONFERENCE CALL DETAILS:
Date: Wednesday, August 13, 2025
Time: 8:30 a.m. ET
Dial-in: 1-877-407-0792 or 1-201-689-8263
Call me™: globenewswire.com
Participants can use Guest dial-in #s above and be answered by an operator OR click the Call me link for instant telephone access to the event. *Available 15 minutes prior to scheduled start time.
Replay Dial-in: 1-844-512-2921 or 1-412-317-6671
Available 1:00 p.m. ET, Wednesday, August 13, 2025, until 11:59 p.m. ET, Wednesday, August 27, 2025
Conference ID: 13755395
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