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NCT04995653 (SER-155 in Graft vs. Host Disease): BVCT ex-ante prediction vs. reported outcome

On 12 May 2024, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 12 Sep 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically borderline significant and commercially insufficient (weak efficacy).

Clinical Trial

NCTID
NCT04995653
Drug Name
SER-155
Drug MoA
oral 16-strain cultivated microbiome therapeutic
Drug Modality
microbiome therapeutic
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
Graft vs. Host Disease (GvHD)
Human Patients
60
Sponsor
Seres Therapeutics
Phase
Phase 1

Prediction of , index 1594

Prospective Prediction
Prediction Index
1594
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit with inferior-to-steroid-or-ruxolitinib efficacy)
Technical Prediction
SUCCESS (statistically maybe significant yet weak clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
123 days in advance
Readout Data Interpretation
SER155 achieved a lower-than-placebo incidence of bacterial bloodstream infections (BSIs) (10% vs 42.9% p=0.0423) yet insignificant incidence of febrile neutropenia (p=0.4674).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically borderline significant and commercially insufficient (weak efficacy)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 1b Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of SER-155 in Adults Undergoing Hematopoietic Stem Cell Transplantation (HSCT) to Reduce the Risk of Infection and Graft vs. Host Disease (GvHD)
Phase
Phase 1
Status
Completed
Enrollment
60
Lead sponsor
Seres Therapeutics, Inc.
Conditions
Allogeneic Hematopoietic Stem Cell Transplantation
Interventions
DRUG: Vancomycin Pre-Treatment; DRUG: Vancomycin Placebo; DRUG: SER-155; DRUG: SER-155 Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2021-11-24
Primary completion
2024-07-23
Completion
2024-07-23
Primary outcomes
  • Safety and tolerability of SER-155, including incidence and severity of adverse events, serious adverse events, or adverse events of special interest (Day 100)
  • Engraftment of SER-155 (Day 100)

NCT04995653 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials