Vertex Pharmaceuticals IncorporatedNASDAQ: VRTX

Vertex Presents Positive Data for Zimislecel in Type 1 Diabetes at the American Diabetes Association 85th Scientific Sessions

· Issued by Vertex Pharmaceuticals Incorporated via Business Wire
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– Results from the study continue to demonstrate the transformative potential of zimislecel with consistent and durable patient benefit –

– All 12 patients with at least one year of follow-up who received a full dose of zimislecel as a single infusion achieved ADA-recommended target HbA1c levels 70% time-in-range (70-180 mg/dL), and 10/12 patients were insulin free –

– Data presented at ADA simultaneously published in the New England Journal of Medicine –

– Vertex to host investor webcast tonight, June 20, 2025, at 7:15 p.m. CT / 8:15 p.m. ET –

BOSTON--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced simultaneous presentation and publication of updated data from the Phase 1/2 portion of the Phase 1/2/3 FORWARD-101 clinical trial of zimislecel (VX-880), an investigational stem cell-derived, fully differentiated islet cell therapy, in people with type 1 diabetes (T1D) with impaired hypoglycemic awareness and severe hypoglycemic events (SHEs). The data were featured in an oral presentation at the American Diabetes Association (ADA) annual conference in Chicago as part of the symposium, “Innovation and Progress in Stem Cell-Derived Islet-Cell Replacement Therapy,” from 6:15-6:30 p.m. CT (abstract 2025-A-1921) and published online by the New England Journal of Medicine.

The data are from 12 patients who received the full dose of zimislecel as a single infusion and were followed for at least one year, as of October 2024. Results from the study to date continue to demonstrate the transformative potential of zimislecel with consistent and durable patient benefit with longer follow-up. All 12 participants:

  • Demonstrated engraftment with glucose-responsive endogenous C-peptide production, which was durable through one year of follow-up.
  • Achieved the ADA targets of HbA1c 70%.
  • Were free of SHEs from day 90 onwards.
  • Had a reduction in exogenous insulin use (mean reduction in daily insulin dose: 92%).
    • 10/12 (83%) no longer required exogenous insulin at Month 12.
  • Achieved the Phase 1/2 primary endpoint of elimination of SHEs with HbA1c