Latest trial suggests progress for people living with type 1 diabetes to become insulin free
New study presented at American Diabetes Association 85th Scientific Sessions.
A newly published report offers hope for people living with type 1 diabetes of an insulin free future.
Researchers presented the results of a study on the zimislecel treatment at the recent American Diabetes Association (ADA) 85th Scientific Sessions.
Zimislecel is an allogeneic stem cell–derived islet-cell therapy, with tests carried out in people with type 1 diabetes with impaired hypoglycaemic (low blood glucose) awareness and severe hypoglycaemic events (also known as hypos).
Researchers from Vertex Pharmaceuticals Incorporated have published their findings in the New England Journal of Medicine.
Researchers said that of 12 patients involved in the study with at least one year of follow-up who received a full dose of zimislecel as a single infusion achieved ADA-recommended target HbA1c levels, of which 10 were insulin free.
Researchers concluded: “The results of this small, short-term study involving persons with type 1 diabetes support the hypothesis that zimislecel can restore physiologic islet function, warranting further clinical investigation.”
Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex, said: “These data on the first fully differentiated, stem cell-derived, off-the-shelf islet cell therapy continue to be unprecedented. The magnitude, consistency and durability of the results from all 12 patients with more than one year of follow-up reinforce the transformative potential of zimislecel for people living with type 1 diabetes complicated by severe hypoglycaemia. We are excited to complete enrolment and dosing in the Phase 1/2/3 Program and look forward to potential regulatory submissions next year.”
Michael R. Rickels, M.D., M.S., Medical Director, Pancreatic Islet Cell Transplant Program, Willard and Rhoda Ware Professor in Diabetes and Metabolic Diseases in the Perelman School of Medicine at the University of Pennsylvania, and Presenting Author and Steering Committee Co-Chair for the zimislecel clinical program, and report author, said: “It is remarkable to see 10 out of 12 patients with baseline HbA1c above 7% and multiple severe hypoglycaemic events reach consensus targets for glycaemic control by both HbA1c and time in range as well as elimination of severe hypoglycaemic events. As I think about my patients and the unmet need in the type 1 diabetes community, the results we have seen so far for restoring endogenous insulin secretion with a stem cell-derived islet therapy bring me hope and confidence for a transformative treatment option for individuals with type 1 diabetes in the not-so-distant future.”
Read the report in the New England Journal of Medicine
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