FDA Lifts Clinical Hold On Vertex's Initial-Stage Diabetes Study

The U.S. Food and Drug Administration (FDA) has lifted the clinical hold placed on Vertex Pharmaceuticals’ VRTX Phase 1/2 clinical trial of VX-880 for patients with type 1 diabetes (T1D).

The ongoing Phase 1/2 clinical study is designed to evaluate VX-880 in patients who have T1D with impaired hypoglycemic awareness and severe hypoglycemia.

Till date, 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.

The Part B will evaluate safety and efficacy in five patients at the target dose before expanding to additional patients in Part C.

In early May 2022, the VX-880 Phase 1/2 clinical study was placed on hold in the U.S. by the Food and Drug Administration (FDA) due to a determination that there is insufficient information to support dose escalation with the product.

Vertex shares are trading high at $287.47 on Tuesday during pre-market session.