Spectral Medical Enrolls Patient 82 in Its Phase 3 FDA Tigris Septic Shock Trial

• New patient enrollment sites accelerating screening activity
• Screening activity exceeding 100 patients per week
• Approaching interim enrollment target of 90 patients
  

TORONTO, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock.

Enrollment:

• Initiated 2024 with robust site activity to start the new year:
  
  • Enrolled patient 82 during the first week of January.
  • Post-holiday break, strong screening activity resumed with more than 100 patients screened per week.
• Closing in on the interim enrollment target of 90 patients (“Interim Enrollment”); at Interim Enrollment, Baxter International (NYSE.BAX) has the option to make the second non-dilutive milestone payment to Spectral to maintain its PMX exclusive distribution rights.
• Crude mortality results at both 28-day (primary endpoint) and at one year, thus far, continue to exceed efficacy targets.
  

Trial Sites:

• Near term onboarding of six new, high quality clinical sites.
  
  • Expect significant site onboarding activity during the first quarter of 2024.

Dr. John Kellum, Chief Medical Officer of Spectral, commented, “We are pleased to see that our clinical sites have returned from the December holiday season and are experiencing robust enrollment activities. This resumes the strong enrollment into Tigris which we experienced since holding our Investigator Meeting this past May. We continue to make progress opening additional sites, which should positively impact the pace of enrollment. Overall, we are rapidly advancing our Tigris trial and remain highly encouraged by the outlook, given the fact preliminary mortality data continues to exceed our expectations.”

“We are very excited about our prospects for 2024. The robust enrollment activity to start the new year puts Spectral within striking distance of our interim enrollment milestone of 90 patients, which is expected to play as a major catalyst for the Company,” said Chris Seto, Chief Executive Officer of Spectral Medical. “Additionally, with 68 patients to go, we are entering the final push to fully enroll and finish the Tigris trial.”

About Spectral 

Spectral is a Phase 3 company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.

PMX is approved for therapeutic use in Japan and Europe and has been used safely and effectively on more than 340,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. In July 2022, the U.S. FDA granted Breakthrough Device Designation for PMX for the treatment of endotoxic septic shock. Approximately 330,000 patients are diagnosed with septic shock in North America each year.

The Tigris Trial is a confirmatory study of PMX in addition to standard care vs standard care alone and is designed as a 2:1 randomized trial of 150 patients using Bayesian statistics. Endotoxic septic shock is a malignant form of sepsis https://www.youtube.com/watch?v=6RANrHHi9L8.

The trial methods are detailed in  “Bayesian methods: a potential path forward for sepsis trials”.

Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com.

Forward-looking statement

Information in this news release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral's senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the company’s ability to raise capital and the availability of funds and resources to pursue R&D projects, the recruitment of additional clinical trial sites, the rate of patient enrollment, the successful and timely completion of clinical studies, the success of Baxter’s commercialization efforts, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected.

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.

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