Posted by Michael Wonder on 10 Dec 2024
FDA grants breakthrough therapy designation to Seres Therapeutics’ SER-155 for reduction of bloodstream infections in adults undergoing allogeneic haematopoietic stem cell transplantation
9 December 2024 - Designation based on encouraging Phase 1b clinical data, including that SER-155 resulted in a 77% relative risk reduction in bacterial bloodstream infections versus placebo.
Seres Therapeutics today announced that the US FDA has granted breakthrough therapy designation to SER-155, the Company’s lead investigational program, for the reduction of bloodstream infections in adults undergoing allogeneic haematopoietic stem cell transplant for the treatment of haematological malignancies.
