Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VE303 · 3 trials · 13 indications
Proportion of participants with laboratory-confirmed CDI recurrence before or at Week 8.
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).
Measured in terms of incidence of AEs according to CTCAE V4.0
Characterized the highest well tolerated dose regimen of VE303 using modified PROMIS questionnaire (v1.0)
| 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. |
| Cohort 1 | EXPERIMENTAL | Cohort 1 received oral vancomycin followed by a single dose of VE303. |
| Cohort 2 | EXPERIMENTAL | Cohort 2 received oral vancomycin followed by a single day of 5 doses of VE303. |
| Cohort 3 | EXPERIMENTAL | Cohort 3 received oral vancomycin followed by a single day of 10 doses of VE303. |
| Cohort 4 | EXPERIMENTAL | Cohort 4 received oral vancomycin followed by 5 days of 10 doses daily of VE303. |
| Cohort 5 | EXPERIMENTAL | Cohort 5 received oral vancomycin followed by 14 days of 10 capsules daily of VE303 |
| Cohort 6 | EXPERIMENTAL | Cohort 6 received 21 days of 10 doses daily of VE303 |
| Cohort 7 | EXPERIMENTAL | Cohort 7 received oral vancomycin followed by 10 doses of VE303 daily for 2 days, followed by 2 doses of VE303 daily for 3 days |
| Cohort 8 | EXPERIMENTAL | Cohort 8 received oral vancomycin followed by 10 doses of VE303 daily for 2 days, followed by 2 doses of VE303 daily for 3 days |
| Cohort 9 | EXPERIMENTAL | Cohort 8 received oral vancomycin followed by 10 doses of VE303 daily for 2 days, followed by 2 doses of VE303 daily for 3 days |
| Vancomycin only | PLACEBO_COMPARATOR | This cohort only received oral vancomycin. |
| 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 | Vancomycin, when taken by mouth, is used to treat Clostridium difficile-associated diarrhea. |
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 therapy being studied for the prevention of recurrent Clostridioides difficile infection (CDI), also referred to as Clostridium difficile infection. It is being evaluated in patients with a history of recurrent CDI, as well as in healthy volunteers for early-phase safety studies.
VE303 is being developed by PureTech Health plc, a biopharmaceutical company listed on the London Stock Exchange under the ticker PRTC. The company is advancing VE303 through clinical trials for the prevention of recurrent Clostridioides difficile infection.
VE303 is currently in Phase 3 clinical development. A Phase 3 trial (NCT06237452) is recruiting participants to evaluate VE303 for the prevention of recurrent Clostridioides difficile infection. Earlier Phase 1 and Phase 2 studies have been completed.
VE303 is being studied in a Phase 3 trial (NCT06237452) for prevention of recurrent Clostridioides difficile infection, with an enrollment target of 852 participants. Completed trials include a Phase 2 study (NCT03788434) in patients with recurrent CDI and a Phase 1 first-in-human study (NCT04236778) in healthy volunteers.
VE303 is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for the prevention of recurrent Clostridioides difficile infection. The therapy has not yet received regulatory approval and remains under evaluation in clinical trials.
VE303 is a monoclonal antibody therapy being developed for infectious disease, specifically targeting Clostridioides difficile infection. The drug is designed to address recurrent CDI, though its specific molecular target has not been disclosed in the available clinical trial information.