Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VE303 · 3 trials · 14 indications
Proportion of participants with laboratory-confirmed CDI recurrence before or at Week 8.
An adverse event (AE) or suspected adverse reaction is considered "serious" if, in the view of the investigator, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
This score is a battery of 5 paper-pencil tests that evaluate cognitive and psychomotor processing speed and visuomotor coordination. Scores on each subtest are assigned values based on age-related norms (1+ for scores better than 1 standard deviation (SD) above the normal mean to -3 for scores more than 3 SDs below the normal mean). Combined scores vary from +6 to -18, where +6 is the best function and -18 is worst function.
Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 8 (i.e., 8 weeks after the first dose of study treatment).
| Arm | Type | Description |
|---|---|---|
| VE303 | EXPERIMENTAL | Subjects assigned to the VE303 arm will take 3 capsules containing VE303 per day for 14 days after completing 10 to 21 days of standard of care antibiotic treatment for the qualifying CDI episode. |
| Placebo | PLACEBO_COMPARATOR | Subjects assigned to the placebo arm will take 3 placebo capsules per day for 14 days after completing 10 to 21 days of standard of care antibiotic treatment for the qualifying CDI episode. |
| VE303 High Dose | EXPERIMENTAL | Study subjects assigned the high dose VE303 arm took 10 capsules (dosage: 8.0 × 10\^9 CFU daily) containing VE303 per day for 14 days. |
| VE303 Low Dose | EXPERIMENTAL | Study subjects assigned to the low dose VE303 arm took 2 capsules (dosage: 1.6 × 10\^9 CFU daily) containing VE303 per day for 14 days. |
| Name | Type | Description |
|---|---|---|
| VE303 | BIOLOGICAL | VE303 is a live biotherapeutic product (LBP) consisting of 8 clonally derived, nonpathogenic, nontoxigenic, commensal bacteria strains manufactured under Good Manufacturing Practices (GMP) conditions. |
| Placebo | BIOLOGICAL | Placebo capsules contain microcrystalline cellulose. Placebo capsules are visually identical to and not discernible from VE303 capsules. Placebo capsules will not contain any VE303 drug product. |
| oral vancomycin | DRUG | All enrolled subjects will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d). |
Key Inclusion Criteria (For enrollment in Stage 1: recurrent CDI population): * Age ≥ 12 years where permitted, and ≥ 18 years in other locations, with a laboratory-confirmed qualifying episode of CDI and at least 1 prior occurrence within the last 6 months Key Inclusion Criteria (For enrollment i...
VE303 is an investigational oral microbiome therapeutic being developed by PureTech Health plc for gastrointestinal conditions. It is being studied for the prevention of recurrent Clostridioides difficile infection and for hepatic encephalopathy in patients with cirrhosis. It is not yet approved and remains in clinical development.
VE303 is being developed to prevent recurrent Clostridioides difficile infection, including C. diff infection recurrence, and to treat hepatic encephalopathy in people with cirrhosis. It is an investigational therapy and has not been approved for any indication.
VE303 is being developed by PureTech Health plc, which trades under the ticker PRTC. PureTech is the sponsor of the clinical program evaluating VE303 in recurrent Clostridioides difficile infection and in hepatic encephalopathy associated with cirrhosis.
VE303 has completed Phase 2 studies and is now in a Phase 3 trial for prevention of recurrent Clostridioides difficile infection. A separate Phase 2 study in hepatic encephalopathy has also been completed. VE303 is investigational and has not been approved by the FDA.
VE303 is being evaluated in the recruiting Phase 3 trial NCT06237452 for prevention of recurrent Clostridioides difficile infection, with 852 participants across the United States, Europe, and other countries. Completed studies include the Phase 2 trial NCT04899115 in hepatic encephalopathy and the Phase 2 trial NCT03788434 in recurrent C. difficile infection.
VE303 is described as a small molecule therapeutic in development for gastrointestinal indications. It is being studied in a placebo-controlled, randomized, double-blind Phase 3 trial for recurrent Clostridioides difficile infection and has completed Phase 2 testing in hepatic encephalopathy.