Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vancomycin Pre-Treatment · 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...
Vancomycin Pre-Treatment is an investigational small molecule developed by Seres Therapeutics, Inc. (ticker MCRB) for use in allogeneic hematopoietic stem cell transplantation. It is being studied as a pre-treatment in a Phase 1 clinical program in hematology.
Vancomycin Pre-Treatment is being developed for use in adults undergoing allogeneic hematopoietic stem cell transplantation. The Phase 1 study evaluated its use in this patient population, with enrollment of 60 adults aged 18 years and older.
Vancomycin Pre-Treatment is being developed by Seres Therapeutics, Inc., which trades under the ticker MCRB. Seres Therapeutics is the sponsor of the clinical program studying this asset in allogeneic hematopoietic stem cell transplantation.
Vancomycin Pre-Treatment is in Phase 1 clinical development. The program includes one completed Phase 1 trial with 60 participants. It is an investigational therapy and has not been approved by the FDA for any indication.
Vancomycin Pre-Treatment has been studied in one Phase 1 trial, NCT04995653, titled A Multiple Dose Study to Evaluate Safety, Tolerability, PK, and Efficacy of SER-155 in Adults Undergoing HSCT. The trial was completed, enrolled 60 participants, and was conducted in the United States.
Yes, Vancomycin Pre-Treatment is also known as SER-155. The Phase 1 trial NCT04995653 refers to the investigational therapy as SER-155, while the asset is also described as Vancomycin Pre-Treatment. Both names refer to the same Seres Therapeutics development program.