FDA Lifts Clinical Hold of Vertex’s Type 1 Diabetes Clinical Trial

The FDA has lifted the clinical hold it placed on Vertex Pharmaceuticals’ phase 1/2 clinical trial of VX-880, an investigational treatment for patients with type 1 diabetes.

The agency placed the hold in May 2021, saying it needed to see more data regarding dose escalation for the drug candidate.

VX-880 is a stem cell-derived therapy that is intended to produce insulin in patients with type 1 diabetes with impaired hypoglycemic awareness — the diminished ability to perceive the onset of hypoglycemia — and severe hypoglycemia.

Only three participants have been dosed with the investigational therapy in the study so far.