Approval Probability
TA Base Rate
Adjusted LOA
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Also known as PEC-Direct
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 cell-based therapy being studied for Type 1 Diabetes Mellitus, including Type 1 Diabetes Mellitus With Hypoglycemia. It is a small molecule modality developed by Vertex Pharmaceuticals Incorporated (ticker VRTX). It has been evaluated in Phase 1 clinical trials and is not approved for commercial use.
VC-02 Combination Product is being studied for the treatment of Type 1 Diabetes Mellitus and Type 1 Diabetes Mellitus With Hypoglycemia, including patients with hypoglycemia unawareness. Its clinical program has focused on safety, tolerability, and efficacy in adults 18 years and older. It remains investigational and has not been approved for any indication.
VC-02 Combination Product is developed by Vertex Pharmaceuticals Incorporated, which trades under the ticker VRTX. Vertex is the sponsor of the clinical program evaluating the product in Type 1 Diabetes Mellitus. The asset is also referred to as PEC-Direct.
VC-02 Combination Product is in Phase 1 clinical development. Two Phase 1 studies have been completed, and no active trials are currently listed. The program has enrolled a total of 49 participants across its completed studies. The product is investigational and has not received FDA approval.
VC-02 Combination Product has been evaluated in two completed Phase 1 trials. NCT03163511 studied safety, tolerability, and efficacy in Type 1 Diabetes Mellitus with hypoglycemia unawareness across the United States, Belgium, and Canada, enrolling 49 participants. NCT03162926 assessed safety and tolerability in Type 1 Diabetes Mellitus in Canada, enrolling 3 participants.
Yes, VC-02 Combination Product is also known as PEC-Direct. Both names refer to the same investigational Vertex Pharmaceuticals asset being studied in Type 1 Diabetes Mellitus. Investors and researchers searching for PEC-Direct will find the same Phase 1 program and clinical trial record under the VC-02 Combination Product name.