Matisse Advances Sepsis Programme Following Positive Phase I Results

Matisse Pharmaceuticals has announced promising topline results from a Phase I study evaluating a 120-hour continuous IV infusion of M6229 in healthy participants. The trial met its primary goals, confirming favourable safety, tolerability, and predictable pharmacokinetics during prolonged infusion.

These findings, combined with results from an earlier study in intensive care sepsis patients, will guide the design of an upcoming Phase II trial focused on determining an optimal dosing strategy. Matisse plans to submit regulatory applications to begin the study in Europe, Asia, and the US.

The placebo-controlled, single-blind, randomised Phase I trial was conducted by Charité Research Organisation in Berlin. Previous clinical research, including a 2024 trial involving a six-hour IV infusion in critically ill sepsis subjects, also demonstrated positive safety outcomes.

Sepsis continues to be a major global health challenge, affecting 49 million people annually with mortality rates above 20%, underscoring the need for new therapeutic options like M6229.

17-11-2025