Teplizumab, an investigational anti-CD3 monoclonal antibody, has been able to delay the onset of type 1 diabetes in patients for up to two years, according to the results from the TrialNet study.
The findings were presented at the American Diabetes Association (ADA) 2019 Scientific Sessions. The results were simultaneously published in the New England Journal of Medicine.
Type 1 diabetes is one of the most common chronic diseases of childhood and is also diagnosed among adults. The drug act by modifying CD8+ T lymphocytes, which are thought to be involved in beta-cell destruction.
“This is the first time we have showed that immune therapy can delay progression to type 1 diabetes,” noted the lead investigator Kevan Herold, MD, professor of immunobiology and internal medicine at Yale University, New Haven, Connecticut in a press release.
The study involved 76 relatives (age ≥ 8 years) of patients with type 1 diabetes who had two or more autoantibodies known to be associated with the condition and abnormal glucose tolerance. 72% of them were children, and 64% were siblings of patients with type 1 diabetes.
They were randomized to 14 daily outpatient infusions of teplizumab or saline (n = 32) and then followed with oral glucose tolerance testing at 6-month intervals.
During the 7-year study, 72% of patients in the placebo group were diagnosed with type 1 diabetes, compared with 43% of patients who received teplizumab.
The teplizumab group reportedly showed a lower annualized rate of type 1 diabetes of 14.9% compared to 35.9% in the placebo group.
The study was conducted by Type 1 Diabetes TrialNet, a US National Institutes of Health (NIH) funded research consortium that aims to prevent type 1 diabetes or slow its progression soon after diagnosis.
“We hope to bring wider recognition to the fact that type 1 diabetes is an autoimmune disease that can be treated with immune therapy, similar to other autoimmune diseases.”stated Carla J. Greenbaum, TrialNet chair.
“We now understand that essentially all close relatives of people with type 1 diabetes and who also have multiple antibodies can be considered as having the early asymptomatic form of the disease. Just as we treat the asymptomatic presence of hypertension to prevent a heart attack or a stroke, these findings provide strong evidence we are approaching a future in which we can identify and treat type 1 diabetes long before symptoms occur.” she said
Based on these phase 2 results, Teplizumab is currently being assessed in newly diagnosed type 1 diabetes patients in the phase 3 PROTECT study which has commenced this April.