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A single infusion of VX-880 offers the potential to transform type 1 diabetes management. This study was presented at the European Association for the Study of Diabetes Congress 2025. In this phase 1/2 study, 12 adults with impaired hypoglycemia awareness and multiple severe hypoglycemic episodes received VX-880 under standard immunosuppression. At baseline, all participants had undetectable fasting C-peptide and frequent hypoglycemia.

By day 90, all participants demonstrated engraftment with glucose-responsive C-peptide production, which persisted through 12 months. Hemoglobin A1c decreased from a mean of 7.8% at baseline to 6.0% at Month 12, and time in range improved from 49.5% to 93%. Severe hypoglycemic episodes were eliminated after Day 90, and exogenous insulin use decreased by a mean of 92%, with 83% of participants no longer requiring insulin at one year.

Adverse events were generally mild or moderate, with no VX-880-related serious events. Two unrelated deaths were previously reported. These results highlight VX-880’s potential as a durable, allogeneic islet cell therapy capable of restoring glycemic control and reducing the burden of insulin therapy in type 1 diabetes.

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Key highlights
  • VX-880 is an allogeneic, stem cell-derived, fully differentiated islet cell therapy for type 1 diabetes.
  • One-year follow-up showed durable C-peptide production, improved hemoglobin A1c, and time in range above 70%.
  • Most participants significantly reduced or stopped exogenous insulin and experienced no severe hypoglycemic episodes.
     
Source

De Koning EJ, Rickels MR, Witkowski P, et al. Durable glycaemic control and elimination of exogenous insulin use with VX-880 in patients with type 1 diabetes: VX-880-101 (FORWARD). Presented at: 61st EASD Annual Meeting of the European Association for the Study of Diabetes; September 15-19, 2025; Vienna, Austria. Diabetologia. 2025:166. https://link.springer.com/article/10.1007/s00125-025-06497-1#Sec28 

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VX-880 Stem Cell Therapy Shows Durable Glycemic Control in Type 1 Diabetes
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Single infusion restores C-peptide production, eliminates severe hypoglycemia, and reduces insulin dependence.
 

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