Spectral Medical Provides Tigris Trial Update
14 Dezember 2023 - 2:00PM
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:
- Robust enrollment activity since the
end of October, with 81 patients enrolled to date,
- Seven patients enrolled over the
last eight weeks
- Screening activity at current sites
remains strong with 100+ patients screened per week
- Closing in on
the interim enrollment target of 90 patients (“Interim
Enrollment”); at Interim Enrollment, Baxter has the option to make
the second 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:
- Currently 20 Tigris trial sites,
with near term onboarding of new, high quality clinical sites.
- Clinical Trial Agreements (“CTA”)
either executed or in final revision phase at six new clinical
sites.
EDEN Study:
- Completed the
EDEN study, a parallel observational study, in which data is
collected on patients with septic shock even if ineligible for
Tigris. The EDEN study is among the largest ever to examine the
full range of septic shock and its relation to organ failure and
endotoxin activity. These data will inform subsequent discussions
with the FDA on labelling for PMX and provide important data on
potential expanded indications for PMX.
Dr. John Kellum, Chief Medical Officer of
Spectral, commented, “Since the end of October, we experienced
strong enrollment into Tigris despite the U.S. Thanksgiving
holiday, with seven patient enrollments in the last eight weeks. We
continue to make progress opening additional sites, which should
positively impact the pace of enrollment. Additionally, the high
rates of influenza that we are witnessing across the southern U.S.
and California could have a positive impact on our enrollment, as
influenza is often a trigger for bacterial sepsis. 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 pleased with the pace of enrollment
activity since holding our Investigator Meeting this past May. The
sustained enrollment activity over these past seven months has put
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.
As a reminder, under the exclusive distribution
agreement between Spectral and Baxter International (NYSE: BAX),
following the enrollment of 90 patients, Baxter has the option to
provide a second milestone payment to Spectral in order to affirm
and maintain its exclusive distribution rights to PMX.
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.
For further information, please contact:
Ali Mahdavi |
David Waldman/Natalya
Rudman |
Chris Seto |
Capital Markets & Investor
Relations |
US Investor Relations |
CEO |
Spinnaker Capital Markets
Inc. |
Crescendo Communications,
LLC |
Spectral Medical Inc. |
416-962-3300 |
212-671-1020 |
|
am@spinnakercmi.com |
edt@crescendo-ir.com |
cseto@spectraldx.com |
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