50 Patients Randomized to Date out of the 150 Total Target to be Enrolled
Reports Significant Uptick in Screening and Enrollment Activities
Dr.
In addition, we are increasing our trial sites for 2023. Since the FDA approved the expansion of clinical trial sites to a total of 25, we are now actively onboarding additional sites, while removing sites that have underperformed, in order to focus our resources. As a result, we anticipate 18-20 sites to be onboarded and actively enrolling patients by the end of the first quarter of 2023. In turn, we believe this will enable us to accelerate patient enrollment and more rapidly reach our 150-patient target.”
Corporate Highlights
Tigris Trial
- Patient Enrollment
Total of 50 patients randomized to-date out of the 150 total to be enrolled in Tigris, with preliminary topline data continuing to exceed expectations.- Specifically, we added approximately 30% of our total enrollment target in the second half of 2022 alone;
- We are also nearing our interim enrollment target of 90 patients (“Interim Enrollment”); at Interim Enrollment,
Baxter has the right to view the trial data, and subsequently the option to make the second milestone payment to Spectral to maintain its exclusive distribution rights.
- Specifically, we added approximately 30% of our total enrollment target in the second half of 2022 alone;
- Tigris Clinical Trial Sites
There are currently 15 Tigris sites onboarded and actively enrolling patients. We have actively removed underperforming sites while aggressively pursuing the onboarding process of additional sites.January 11, 2023 , onboarded theMedical University of South Carolina and is open for enrollment;- Anticipate Tigris site no.16, a premier northern
California health science center, to be onboarded in the next 1-2 weeks; - There are 6 potential Tigris trial sites that are at various stages of our clinical team’s vetting process; and
- We expect to have 18-20 clinical trial sites onboarded by the end of the first quarter of 2023.
- Timing
We continue to focus on finalizing the Tigris trial within the reasonably shortest timelines. To meet final trial enrollment in 2023, we estimate the need for approximately 20 productive trial sites.
Observational Studies
- EUPHAS-2 is a Spectral-sponsored observational study in
Italy using EAA-guided PMX, which is now complete We have reviewed the topline results, which strongly support the preliminary data received from the Tigris trial. These data strengthen our confidence in our ability to achieve a successful trial outcome as well as potential FDA approval. - EDEN is the Company’s ancillary observational study, in which data is collected on patients with sepsis even if ineligible for Tigris. EDEN will capture much needed data on 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.
The Company has onboarded 5 EDEN sites and enrolled 30 patients into the observational study.
PMX Commercialization
- In anticipation of a positive Tigris trial outcome, the Company has been working closely over the last eight months with
Baxter , the Company’s strategic commercial partner, on post-approval marketing plans for PMX commercialization. This includes developing product branding, pricing and roll-out plans with numerousBaxter departments, including marketing, government/regulatory, clinical and reimbursement.Baxter has communicated its intention to undertake a broad marketing campaign on day 1 of FDA approval for PMX- The Company is working with
Baxter on a sub-study to obtain FDA approval for hemoperfusion for Baxter’s Prismax device; the Prismax, with its leading installed base, is anticipated to be the primary device utilized for PMX treatments on commercial launch. January 6, 2023 ,Baxter announced a corporate re-organization, in which it will spin-off its Renal and Acute Therapies business, into an independent, publicly traded entity (“KidneyCo”) in the next 12-18 months. With respect to our partnership withBaxter , the Company has been dealing with the Acute Therapies business unit; as such, we anticipate our exclusive distribution agreement will be transferred to KidneyCo at the time of the spin-off.
For information on Baxter’s spin-off, please visit:
Baxter Announces Strategic Actions to Enhance Operational Effectiveness, Accelerate Innovation for Patients and Drive Value for Shareholders |Baxter
Renal Investor Presentation (q4cdn.com)
- The Company is working with
i-Dialco
As previously announced, we entered into a strategic joint venture with
About Spectral
Spectral is a Phase 3 company seeking
PMX is approved for therapeutic use in
Spectral is listed on the
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 availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, 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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Capital Markets & Investor Relations | US Investor Relations | CFO |
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am@spinnakercmi.com | edt@crescendo-ir.com | bmcinnis@spectraldx.com |
Source:
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