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SER-109 · 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...
SER-109 is an investigational therapy being developed for the prevention of recurrent Clostridium difficile infection, also referred to as Clostridioides difficile infection. It is intended for adults who have experienced repeat episodes of this bacterial infection. SER-109 is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
SER-109 is a microbiome-based therapeutic designed to restore the natural balance of bacteria in the gut, which is disrupted by antibiotic treatment for Clostridium difficile infection. By delivering a defined composition of bacterial spores, SER-109 aims to prevent the recurrence of C. difficile infection. It is being developed as an oral, non-antibiotic approach.
SER-109 is being developed by Seres Therapeutics, Inc., a biopharmaceutical company focused on microbiome therapeutics. Seres Therapeutics is publicly traded under the ticker symbol MCRB on the Nasdaq stock exchange. The company is conducting clinical trials to evaluate the safety and efficacy of SER-109 for recurrent Clostridium difficile infection.
SER-109 is in Phase 3 clinical development for the prevention of recurrent Clostridium difficile infection. It is an investigational therapy, meaning it has not yet received approval from the U.S. Food and Drug Administration or other regulatory agencies. The Phase 3 program includes completed trials evaluating the treatment in adult patients with recurrent C. difficile infection.
SER-109 has been studied in several clinical trials, including NCT02437487, a Phase 2 study versus placebo to prevent recurrent Clostridium difficile infection, and NCT03183128, the Phase 3 ECOSPOR III trial comparing SER-109 to placebo in adults with recurrent C. difficile infection. Additionally, NCT03183141, the ECOSPOR IV study, is an open-label Phase 3 trial evaluating SER-109 in recurrent Clostridioides difficile infection.
SER-109 is not a fecal transplant. It is a purified, defined composition of bacterial spores derived from healthy donor stool, formulated as an oral capsule. Unlike fecal microbiota transplantation, which uses unprocessed stool, SER-109 is manufactured to a standardized product. It is designed to prevent recurrent Clostridium difficile infection by restoring gut microbiome diversity.