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Vertex trial for hypoglycaemia therapy shows early promise

New data now reveals significant increases in the blood glucose time-in-range compared to baseline, following VX-880 dosage.

Vertex Pharmaceuticals has provided additional data on patients dosed in its phase 1/2 clinical trial of VX-880. The therapy is an investigational stem cell-derived, fully differentiated pancreatic islet cell

replacement therapy for people with type 1 diabetes (T1D), impaired hypoglycaemic awareness and severe hypoglycaemia.

Two patients treated with half the target dose of VX-880 had previously achieved glucose-responsive insulin production, improvements in glycaemic control and reductions in exogenous insulin requirements. The new data now reveals significant increases in the blood glucose time-in-range compared to baseline, following treatment.

Patient 1 showed a blood glucose time-in-range increase from 40.1% at baseline to 99.9% on day 270 and was insulin-independent. Meanwhile, patient 2 showed a time-in-range increase from 35.9% at baseline to 51.9% on Day 150, with a 30% reduction in exogenous insulin use.

VX-880 has been generally well-tolerated in all patients dosed to date, with the majority of adverse events being mild or moderate.

“The glucose time-in-range data presented today at [the American Diabetes Association] ADA demonstrate the remarkable glycaemic control that can be achieved after treatment with VX-880,” reflected Bastiano Sanna, chief of cell and genetic therapies at Vertex. “Elevations in blood sugar are important to control, as are fluctuations over time, as both increase the risk of complications in patients with T1D.”

“As a treating physician, I have seen the profound burden of this disease on patients, especially those who experience severe hypoglycaemia. The ability to restore a patient’s islet function and improve glycaemic control, and subsequently reduce exogenous insulin dependence, has significant potential to improve patient’s lives,” added Camillo Ricordi, steering committee chair for the VX-880 clinical trial.

To date, three patients have been dosed in the Phase 1/2 study with VX-880. Two patients received half the target dose of cells in part A of the study. A third patient has also received the full target dose in part B of the study.