The press release from the American Diabetes Association presents promising findings from an ongoing clinical trial of VX-880, a novel stem cell-derived islet cell therapy for individuals with type 1 diabetes (T1D). The study, presented at the 83rd Scientific Sessions of the American Diabetes Association, demonstrates the potential of this therapy as a future treatment option for T1D patients.
The trial involves adult T1D patients with impaired hypoglycemic awareness and severe hypoglycemia. All patients treated with VX-880 had undetectable insulin secretion and a history of recurrent severe hypoglycemic events (SHE) in the year prior to treatment.
Post-treatment, all six patients showed restored insulin secretion, improved glycemic control, improved time-in-range, reduction or elimination of exogenous insulin usage, and complete absence of SHEs in the post-Day 90 evaluation period.
Two patients treated with VX-880 for at least 12 months became insulin independent and showed significant improvements in their HbA1c levels. Three additional patients, each administered the full target dose of VX-880 as a single infusion, have had up to 90 days of follow-up and also have shown insulin production, reduction in HbA1c, improvements in time-in-range, and reductions in daily insulin usage.
VX-880 has been generally safe and well tolerated in all patients dosed to date, with a safety profile consistent with immunosuppressant therapy and cadaveric islet cell transplantation. The majority of adverse events were mild or moderate, and there were no serious adverse events related to VX-880 treatment.
The positive safety and efficacy data have led an independent data review committee to recommend moving to Part C of the trial, which allows for concurrent dosing of patients at the full target dose of VX-880. The VX-880 trial has expanded to additional sites that are active and enrolling in Norway, Switzerland, and the Netherlands.