Matisse is preparing for a Phase IIb clinical study of M6229 for the treatment of sepsis. Credit: Matisse Pharmaceuticals B.V.

Matisse Pharmaceuticals has reported positive topline results from the HistoSeps trial, designed to evaluate the tolerability, safety, and pharmacokinetics of M6229 for the treatment of sepsis.

The first in-human trial, conducted at the Amsterdam University Medical Center, involved ten critically ill patients and met its primary objectives.

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It demonstrated favourable tolerability and safety, along with close to dose-proportional pharmacokinetics of six-hour intravenously (IV) administered M6229 in critically ill sepsis patients.

As per the University of Maastricht’s preliminary semi-quantitative plasma histone H3 (H3) analyses, a pharmacodynamic effect was measured with a decrease in plasma histone levels post-administration.

After three days following the infusion, 70% of the patients experienced a reduction in their sequential organ failure assessment (SOFA) score. Further quantitative analyses are underway to confirm these findings.

Matisse Pharmaceuticals chief development officer Kees Groen said: “We are very pleased with the results confirming strong progress in the development of our lead compound M6229 as the first effective treatment for sepsis.

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“The current data give strong guidance to us in the design of a successful phase 2b study, which we expect to run in the US and Europe.”

Matisse is now preparing for a Phase IIb trial, intending to start treatment infusions as early as possible post-sepsis diagnosis.

The company has recently secured funding to support this next phase, with additional funding rounds planned to cover the complete execution of the trial, increased production, and advanced research and development projects.

The World Health Organization identifies sepsis as a leading cause of death, with no effective treatment currently available.