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.”