Spectral Medical Announces Publication of Tigris Trial Methods Paper and Simulation of Results

Tomlinson et al. Bayesian methods: a potential path forward for sepsis trials. Critical Care (2023) 27:432

TORONTO, Nov. 14, 2023 (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 announced the publication of its Tigris trial methods paper in Critical Care, which discusses the use of Bayesian methods in clinical trial design. Simulation studies incorporating historical data from a 179-patient subgroup of Spectral’s EUPHRATES trial combined with data from the ongoing Tigris trial demonstrated an increase in power across a range of observed hypothetical results.

Dr. John Kellum, Chief Medical Officer of Spectral Medical, commented, “We are pleased to see the publication of this paper, in a major scientific journal. The analysis clearly indicates that our trial strategy is highly likely to succeed and not only will this support our FDA approval for PMX, but will also have a major impact on how trials in the ICU are conducted in the future. The simulations involving over 2,000 potential trial results show that using the planned 75% weight on the prior EUPHRATES data, an observed absolute risk reduction for mortality of 7% in Tigris is at approximately the 95% probability threshold for declaring PMX effective. Current results from Tigris are far in excess of this threshold.”

Chris Seto, Chief Executive Officer of Spectral commented, “We are also pleased to see all of our study site investigators participating as authors on the study as we continue to work aggressively to complete the enrollment of our Tigris Trial. We are proud to be a part of this effort to help patients suffering from endotoxic septic shock and hope to bring a new standard of care to the market.”

The Tigris Trial methods paper “Bayesian methods: a potential path forward for sepsis trials” can be accessed at: https://doi.org/10.1186/s13054-023-04717-x

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