Recent Updates
Recently added Catalysts

SER-262

Phase 1

Clostridium Difficile Infection | Small molecule | Other |Seres Therapeutics, Inc.|Last Updated: Feb 6, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment96
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02830542SER-262 Versus Placebo in Adults With Primary Clostridium Difficile Infection to Prevent RecurrencePHASE1 COMPLETED 96 — — Aug 1, 2016Aug 1, 2018Feb 6, 202322 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Safety and tolerability of SER-262 as assessed by incidence of AEs, lab results, vital signs, ECG, and physical examination findings
Up to 24 weeks after treatment
Relative risk of recurrence based on the proportion of subjects experiencing CDI recurrence in each SER-262 cohort compared to placebo up to 8 weeks after treatment
Up to 8 weeks after treatment
Secondary Endpoints
Time to recurrence of CDI
Up to 24 weeks after treatment
Relative risk of recurrence of CDI up to 4, 12, and 24 weeks after treatment
Up to 4, 12, and 24 weeks after treatment
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
SER-262EXPERIMENTALSER-262 \[Single dose: 10(4), 10(5), 10(6), 10(7) or 10(8) SCFUs; Multiple dose 10(6), 10(7), or 10(8) SCFUs\]
PlaceboPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
SER-262DRUGSER-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.
PlaceboDRUGPlacebo 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.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites22

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...

Countries:United States
Unlock Eligibility Criteria