- The FDA has lifted the clinical hold placed on Vertex Pharmaceuticals Inc's VRTX Phase 1/2 trial of VX-880 for people with type 1 diabetes (T1D) with severe hypoglycemia.
- VX-880 is an investigational stem cell-derived, fully differentiated pancreatic islet cell replacement therapy.
- The FDA instituted a clinical hold on the study due to a determination of insufficient information to support dose escalation with the product.
- As a result, the Phase 1/2 trial will be reopened for screening, enrollment, and dosing at multiple sites in the U.S.
- Three patients have been dosed in the Phase 1/2 study with VX-880.
- Two patients received half the target dose of cells in Part A of the study. A third patient has received the full target dose in Part B of the study.
- Part B will evaluate safety and efficacy in five patients at the target dose before expanding to additional patients in Part C.
- Price Action: VRTX shares are up 0.58% at $289.00 during the premarket session on the last check Tuesday.
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