Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SER-262 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| SER-262 | EXPERIMENTAL | SER-262 \[Single dose: 10(4), 10(5), 10(6), 10(7) or 10(8) SCFUs; Multiple dose 10(6), 10(7), or 10(8) SCFUs\] |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| SER-262 | DRUG | SER-262 is a rationally designed, multi-strain Ecobiotic® microbiome therapeutic produced synthetically by in vitro fermentation. It is a consortium of anaerobic, commensal bacteria in spore form, encapsulated for oral administration. |
| 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. |
Inclusion Criteria: 1. Signed informed consent, indicating that the subject understands the purpose of and procedures required for the study. 2. Male or female subjects ≥ 18 years. 3. A primary (first) episode of CDI with documentation of the episode including CDI date, test results, antibiotic tre...
SER-262 is an investigational small molecule being developed for Clostridium difficile infection. It is designed to prevent recurrence of the infection in adults who have had primary Clostridium difficile infection. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
SER-262 is being developed by Seres Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol MCRB. The company is conducting clinical trials to evaluate the safety and efficacy of SER-262 for the prevention of recurrent Clostridium difficile infection.
SER-262 is in Phase 1 clinical development. A Phase 1 clinical trial has been completed, which evaluated the drug versus placebo in adults with primary Clostridium difficile infection to prevent recurrence. SER-262 is investigational and has not been approved by the FDA or other regulatory agencies.
SER-262 has one completed clinical trial, identified as NCT02830542. This Phase 1 study was a randomized, double-blind, placebo-controlled trial conducted in the United States, enrolling 96 adults with primary Clostridium difficile infection to assess the drug's ability to prevent recurrence. The trial is no longer active.
SER-262 is a small molecule designed to prevent recurrence of Clostridium difficile infection. The specific molecular target of SER-262 has not been disclosed in available information, so its exact mechanism of action is not publicly detailed. It is being studied for its ability to reduce the risk of infection recurrence following primary treatment.