The present article provides an overview of the updated data from the Phase I/II Clinical Trial (CT), in patients with Type 1 Diabetes(T1D) and impaired hypoglycemic awareness and severe hypoglycemia. VX-880 is an investigational therapy for T1D that involves allogeneic stem cell-derived, fully differentiated, pancreatic islet cell replacement therapy. The trial consists of three parts: Part A, Part B, and Part C, each with different enrollment and dosing protocols.

In Part A, two patients were enrolled sequentially and received half the target dose of VX-880 and showed restored insulin production and glycemic control. One patient achieved and maintained insulin independence, meeting the defined criteria of at least one week off exogenous insulin, HbA1C ≤7%, post-prandial serum glucose at 90 minutes ≤180 mg/dL, fasting serum glucose ≤126 mg/dL, and fasting or stimulated C-peptide ≥166 pmol/L (measured during mixed-meal tolerance test). The safety profile of VX-880 in Part A was consistent with the immunosuppressive regimen used in the study and the perioperative period. Part B of the trial was sequentially enrolled 5 patients, who received the full (target) dose of VX-880. Later, in Part B, fully enrolled multiple patients have been dosed with the full (target) dose The study mentions that longer-term data on the patients from Part A and new data on patients receiving the full dose in Part B will be provided in the presentation. The significant results represent the first CT of allogeneic, fully differentiated, insulin-producing stem cell-derived islets. It demonstrated the potential to restore insulin production, improve glycemic control, and achieve insulin independence in patients with T1D.

836-P. American Diabetes Association (ADA), 23rd June- 26th June, San Diego, CA.