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Also known as SER-109
Vowst · 3 trials · 3 indications
Cohort 1: Recurrence of CDI up to 8 Weeks after treatment. Recurrence was determined by stool Clostridioides difficile toxin assay. Sustained clinical response was the absence of CDI recurrence up to 8 Weeks after treatment.
Cohort 2: Recurrence of CDI up to 8 and 12 Weeks after treatment. Recurrence was determined by stool Clostridioides difficile toxin assay. Sustained clinical response was the absence of CDI recurrence up to 8 and 12 Weeks after treatment.
Recurrence of CDI up to 8 Weeks after initiation of treatment. Recurrence was determined by stool Clostridioides difficile toxin assay.
| Arm | Type | Description |
|---|---|---|
| SER-109 | EXPERIMENTAL | Received oral dose of SER-109 |
| Placebo | PLACEBO_COMPARATOR | Received matching placebo |
| Name | Type | Description |
|---|---|---|
| SER-109 | BIOLOGICAL | SER-109, an oral, biologically derived, live microbiome therapeutic that comprises purified bacterial spores |
| Placebo | DRUG | Placebo will be identical to the investigational product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline(0.9%). |
Cohort 1 Main Inclusion Criteria: 1. Previously enrolled in Study SERES-012, had CDI recurrence within 8 weeks after receipt of a treatment regimen of SER-109 or placebo 2. Signed informed consent prior to initiation of any study-specific procedure or treatment. The subject, or their legally author...
Vowst is used for recurrent Clostridioides difficile infection, also called Clostridium difficile infection or CDI. It is an investigational microbiome-based therapeutic developed by Seres Therapeutics for adults with recurrent CDI, studied in Phase 3 trials including ECOSPOR III and ECOSPOR IV.
Vowst is developed by Seres Therapeutics, Inc., which trades on the Nasdaq under the ticker MCRB. The company is the sponsor of the clinical program evaluating Vowst, also known as SER-109, in recurrent Clostridioides difficile infection.
Vowst is in Phase 3 clinical development. Its Phase 3 program includes the completed ECOSPOR III and ECOSPOR IV trials in adults with recurrent Clostridioides difficile infection, and an earlier completed Phase 2 study. It is investigational and has not been approved by the FDA.
Vowst has been studied in three completed trials: the Phase 3 ECOSPOR IV trial (NCT03183141) with 263 participants, the Phase 3 ECOSPOR III trial (NCT03183128) with 182 participants, and the Phase 2 trial NCT02437487 with 89 participants. All enrolled adults in the United States and Canada.
Yes, Vowst is the same drug as SER-109. SER-109 is the earlier development name used in the clinical trial titles, including ECOSPOR III and ECOSPOR IV, while Vowst is the current name for the same Seres Therapeutics product candidate.