Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SER-155 · 1 trial · 1 indication
Incidence and severity of participants with adverse events, serious adverse events, or adverse events of special interest
Prevalence of SER-155 strains in subject stool measured before and after treatment courses
| Arm | Type | Description |
|---|---|---|
| Cohort 1 - Open Label Study | EXPERIMENTAL | Vancomycin \& SER-155 |
| Cohort 2 - Randomized, Double-Blind, Placebo-Controlled Study | EXPERIMENTAL | Vancomycin \& SER-155 OR Vancomycin placebo \& SER-155 placebo |
| Name | Type | Description |
|---|---|---|
| Vancomycin Pre-Treatment | DRUG | Four times daily dosing with Vancomycin |
| Vancomycin Placebo | DRUG | Four times daily dosing with Vancomycin Placebo |
| SER-155 | DRUG | Once daily dosing with SER-155 |
| SER-155 Placebo | DRUG | Once daily dosing with SER-155 placebo |
Inclusion Criteria: * Male and female subjects ≥ 18 years of age undergoing HSCT. * Planning to undergo allogeneic hematopoietic stem cell transplantation from a human leukocyte antigen matched related donor, haploidentical related donor, HLA-matched unrelated donor, or HLA 1-antigen mismatched unr...
SER-155 is an investigational therapy being studied for use in allogeneic hematopoietic stem cell transplantation (HSCT). It is being developed to address needs in this hematology setting, though specific efficacy outcomes are not detailed here. The drug is currently in clinical development and has not been reported as approved.
SER-155 is being developed by Seres Therapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker MCRB. Seres Therapeutics is advancing SER-155 through clinical trials for allogeneic hematopoietic stem cell transplantation.
SER-155 is in Phase 1 clinical development. It has completed a Phase 1 trial, and the drug remains investigational. SER-155 has received Breakthrough Therapy and Fast Track designations from the FDA, indicating its potential to address serious conditions.
SER-155 has been studied in one clinical trial, NCT04995653, titled 'A Multiple Dose Study to Evaluate Safety, Tolerability, PK, and Efficacy of SER-155 in Adults Undergoing HSCT.' This Phase 1 trial was completed and enrolled 60 participants in the United States.
SER-155 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial. The FDA has granted SER-155 Breakthrough Therapy and Fast Track designations, which are intended to expedite development and review, but approval has not been reported.