Vertex Pharmaceuticals presented updated data from the Phase 1/2 portion of the FORWARD-101 clinical trial of zimislecel (VX-880) at the American Diabetes Association (ADA) annual conference. Zimislecel is an investigational stem cell-derived, fully differentiated islet cell therapy for Type 1 Diabetes (T1D) patients with impaired hypoglycemic awareness and severe hypoglycemic events.
Results from 12 patients who received a full dose and were followed for at least one year showed consistent and durable patient benefit. All 12 participants achieved ADA-recommended target HbA1c levels below 7% and over 70% time-in-range, with 10 out of 12 patients becoming insulin-free.
Zimislecel continued to be generally well tolerated, with most adverse events being mild or moderate, and no serious adverse events related to the treatment. These data were simultaneously published online by the New England Journal of Medicine, reinforcing the transformative potential of zimislecel for T1D.
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