What's Happening?
Matisse Pharmaceuticals has completed a Phase 1 study of its lead compound M6229, evaluating its safety, tolerability, and pharmacokinetics in healthy volunteers. The study, which involved a 120-hour continuous
intravenous infusion, met its primary objectives, showing favorable safety and tolerability. These results, along with previous data from sepsis patients, will inform the design of a Phase 2 study.
Why It's Important?
Sepsis is a leading cause of death worldwide, with no effective treatment currently approved. Matisse's M6229 offers a potential new approach by targeting cytotoxic histones that contribute to organ failure in sepsis patients. The successful completion of the Phase 1 study is a critical step towards developing a treatment that could significantly reduce mortality and improve outcomes for sepsis patients.
What's Next?
Matisse plans to submit regulatory dossiers for the Phase 2 study in the US, Europe, and Asia. The upcoming study will focus on selecting the optimal dosing strategy for sepsis patients. If successful, M6229 could become a groundbreaking treatment for sepsis, addressing a major unmet medical need and potentially saving millions of lives.
