Matisse Pharmaceuticals reported positive Phase I top-line results from a randomized, placebo-controlled, single-blind study in which healthy volunteers received a 120-hour continuous IV infusion of M6229. The trial met its primary endpoints, showing favourable safety, tolerability and predictable pharmacokinetics during prolonged infusion. Combined with earlier ICU sepsis and a prior six-hour infusion trial, these data will guide a planned Phase II sepsis study focused on dosing strategy. Matisse intends to seek regulatory approvals to run the Phase II trial in Europe, Asia and the US.
Matisse Reports Positive Phase I Results for 120‑Hour M6229 IV Infusion, Clearing Path for Phase II Sepsis Study
Matisse Pharmaceuticals reported positive Phase I top-line results from a randomized, placebo-controlled, single-blind study in which healthy volunteers received a 120-hour continuous IV infusion of M6229. The trial met its primary endpoints, showing favourable safety, tolerability and predictable pharmacokinetics during prolonged infusion. Combined with earlier ICU sepsis and a prior six-hour infusion trial, these data will guide a planned Phase II sepsis study focused on dosing strategy. Matisse intends to seek regulatory approvals to run the Phase II trial in Europe, Asia and the US.
02:06 PM, 11/14/2025Health
Matisse announces encouraging Phase I data for extended M6229 infusion
Matisse Pharmaceuticals has reported positive top-line results from a Phase I study in which healthy volunteers received a 120-hour continuous intravenous (IV) infusion of M6229. The randomized, placebo-controlled, single-blind trial was executed and managed by Charité Research Organisation in Berlin and was designed to evaluate pharmacokinetics (PK), safety and tolerability during a prolonged infusion.
The study met its primary endpoints: investigators observed a favourable safety and tolerability profile, and M6229 showed predictable pharmacokinetic behaviour across the extended infusion period. These findings support the compound's stability and dosing predictability during prolonged IV administration.
Combined with data from an earlier intensive-care sepsis study and a prior six-hour infusion trial completed in 2024, the new Phase I results will inform the design of a planned Phase II clinical trial in sepsis. The upcoming Phase II study will focus on identifying an optimal dosing strategy for patients with sepsis.
"We believe that a prolonged infusion duration could offer an effective solution for irreversibly stopping the harmful inflammatory responses that occur in sepsis patients," said Kees Groen, Chief Development Officer at Matisse Pharmaceuticals. "These data mark an important step toward applying an extended-infusion approach in our Phase II study, which is now in preparation."
Matisse plans to submit regulatory dossiers to seek approval to run the Phase II trial in Europe, across Asia and in the United States. If approved, the company will use the combined healthy-volunteer and ICU data to refine dosing, safety monitoring and efficacy endpoints for sepsis patients.
Context: Sepsis remains a major global health challenge. The World Health Organization estimates sepsis affects roughly 49 million people annually and carries a mortality rate exceeding 20%. Early-phase clinical signals of safety and predictable PK do not guarantee clinical efficacy; further trials are needed to demonstrate benefit in sepsis patients.
Source: Originally reported by Clinical Trials Arena (a GlobalData brand). Information is presented for general informational purposes and should not be relied on as medical or regulatory advice.