Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VC-02 Combination Product · 2 trials · 2 indications
Incidence of all AEs and evaluation of causality related to VC-02 combination product, the surgical procedures, and the immunosuppressive drug regimen.
Change from baseline to Week 26 in C-peptide area under the curve from 0 to 4 hours following a mixed meal tolerance test.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | VC-02 Combination Product: Up to ten (10) VC-02-20 implants and up to two (2) VC-02-300 implants |
| Cohort 2 | EXPERIMENTAL | VC-02 Combination Product; Up to twelve units implanted of which up to ten (10) are VC-02-300 implants and the rest are VC-02-20 implants. |
| Single-group | EXPERIMENTAL | Up to six (6) VC-02-20 implants |
| Name | Type | Description |
|---|---|---|
| VC-02 Combination Product | COMBINATION_PRODUCT | PEC-01 cells loaded into a Delivery Device |
| VC-02 Combination Product (aka PEC-Direct) | COMBINATION_PRODUCT | PEC-01 cells loaded into a Delivery Device |
Inclusion Criteria: * Men and non-pregnant women * Diagnosis of T1DM for a minimum of five (5) years * Hypoglycemia unawareness or significant glycemic lability * Stable diabetic treatment * Willingness to use a continuous glucose meter * Acceptable candidate for implantation Exclusion Criteria: ...
VC-02 Combination Product is an investigational small molecule being developed for Type 1 Diabetes Mellitus and Type 1 Diabetes Mellitus With Hypoglycemia. It is intended for adults aged 18 years and older. The product is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
VC-02 Combination Product is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company listed on the NASDAQ under the ticker symbol VRTX. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy for Type 1 Diabetes Mellitus.
VC-02 Combination Product is in Phase 1 clinical development. Two Phase 1 trials have been completed, one with 3 participants and another with 49 participants. The product remains investigational and is not yet approved for commercial use.
VC-02 Combination Product has been studied in two completed Phase 1 trials. NCT03162926 evaluated safety and tolerability in 3 subjects with Type 1 Diabetes Mellitus in Canada. NCT03163511 assessed safety, tolerability, and efficacy in 49 subjects with Type 1 Diabetes Mellitus and Hypoglycemia Unawareness across the United States, Belgium, and Canada.
VC-02 Combination Product is the full name of the investigational therapy, which is also referred to as VC-02 in clinical trial documentation. The product is being studied for its potential role in treating Type 1 Diabetes Mellitus and related hypoglycemia conditions.