Matisse Pharmaceuticals has reported encouraging top line results from a Phase I trial of a 120-hour continuous intravenous (IV) infusion with M6229 in healthy participants.
The trial is designed to evaluate the pharmacokinetics, safety and tolerability of the lead compound.
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It met its primary objectives, demonstrating a favourable tolerability and safety profile in the subjects, and showed that M6229 has predictable pharmacokinetic behaviour during prolonged infusion.
Data from the healthy participants study, combined with findings from an earlier trial in intensive care sepsis subjects, will support the design and execution of a Phase II clinical trial in sepsis.
The upcoming study will focus on selecting an appropriate dosing strategy for sepsis subjects.
Matisse plans to submit regulatory dossiers seeking approval to conduct the trial in Europe, Asia and the US.
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By GlobalDataCharité Research Organisation in Berlin, Germany, executed and managed the placebo-controlled, single-blind, randomised study.
Matisse Pharmaceuticals chief development officer Kees Groen said: “We believe that a prolonged infusion duration could offer an effective solution for irreversibly stopping the harmful inflammatory responses that occur in sepsis patients.
“With these data we take a very important step in applying this extended infusion in our Phase II study to treat sepsis patients, which is currently in preparation.”
In a previous clinical trial completed in 2024, a six-hour continuous IV infusion of M6229 demonstrated a positive tolerability and safety profile in critically ill sepsis subjects.
Sepsis remains a leading cause of death globally, according to the World Health Organization, affecting 49 million individuals annually with a mortality rate exceeding 20%.
In January 2024, Matisse reported positive topline results from the HistoSeps trial, which was designed to evaluate the tolerability, safety, and pharmacokinetics of M6229 for the treatment of sepsis.
