Vertex shares results from phase 1/2 trial of type 1 diabetes treatment
Betsy Goodfellow | June 24, 2024 | News story | Research and Development | Diabetes, Vertex pharmaceuticals, clinical trial, diabetes
Vertex Pharmaceuticals has announced new data from its phase 1/2 clinical trial of VX-880, an investigational stem cell-derived, fully differentiated islet cell therapy in patients with type 1 diabetes (T1D) with impaired hypoglycaemic awareness and severe hypoglycaemic events (SHEs).
The data included 12 patients who were given a full dose as a single agent in parts B and C of the trial, and are consistent with previously reported results from prior trials, as well as reinforcing the potential of the therapy.
The results showed that following a single full dose infusion of VX-880, all patients demonstrated islet cell engraftment and glucose-responsive insulin production by day 90. At the latest visit, all patients showed improved glycaemic control and achieved ADA-recommended targets for both HbA1c below 7.0% and time-in-range above 70% on continuous glucose monitoring.
All three patients who had at least a year of follow-up, met the primary endpoint of elimination of SHEs with HbA1c <7.0% and the secondary endpoint of insulin independence.
Carmen Bozic MD, executive vice president of global medicines development and medical affairs and chief medical officer at Vertex, commented: “These remarkable data add to the growing body of evidence for VX-880 as a potentially curative therapy for T1D. As we plan toward pivotal development, we are pleased to have secured regulatory approval to expand study enrollment and look forward to advancing this program for patients who have long awaited a transformative therapy.”
Betsy Goodfellow
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