**Vertex announces Type 1 diabetes program update: VX-264 ends, zimislecel progresses toward regulatory submissions**

On March 28, 2025, Vertex Pharmaceuticals announced key updates to its type 1 diabetes (T1D) portfolio. The company has completed enrollment and dosing for Parts A and B of the Phase 1/2 study of VX-264, a cell therapy encapsulated in an immunoprotective device. While VX-264 was generally safe and well tolerated, it failed to show efficacy in increasing insulin production, measured by C-peptide levels. As a result, Vertex will not advance VX-264 to further clinical development but will continue further analyses, including of explanted devices.

Meanwhile, the pivotal trial of zimislecel (VX-880), a fully differentiated islet cell therapy with standard immunosuppression, is on track to complete enrollment and dosing in the first half of 2025. Regulatory submissions are expected in 2026. Zimislecel has received multiple regulatory designations, including RMAT and Fast Track in the US and PRIME status in Europe. Vertex anticipates an initial approval could benefit about 60,000 people with severe T1D in the US and Europe.

Vertex also reaffirmed its commitment to developing additional research-stage approaches for T1D, including gene-edited hypoimmune islet cell therapies and novel encapsulation technologies to reduce or eliminate the need for standard immunosuppression.

Carmen Bozic, M.D., Chief Medical Officer, stated, “Today’s data show that more work needs to be done to advance the ‘cells plus device’ program, and we are committed to doing so. We’re also very pleased with the rapid progress of our zimislecel program.”

More information can be found at [www.vrtx.com](https://www.vrtx.com) or via BusinessWire [here](https://www.businesswire.com/news/home/20250328622122/en/).