Results from the PROTECT study show that teplizumab can preserve beta cell function in children and adolescents newly diagnosed with type 1 diabetes.
Approved by the US FDA in November 2022, teplizumab is an immunotherapy drug proven to delay the onset of type 1 by up to three years in people at high-risk of developing type 1.
The PROTECT study results, published in the New England Journal of Medicine, show that the drug also has the potential to slow the progression of type 1 in people newly diagnosed with the condition.
Meanwhile, there is a separate study looking at the benefits of type 1 diabetes screening for children and young people that this drug could potentially be a part of.
The ELSA Study is recruiting 20,000 children in the UK to explore the feasibility and benefits of screening for type 1 diabetes.
Teplizumab is the first ever disease-modifying drug licensed for type 1 diabetes. It’s an immunotherapy drug, which means it directly interferes with the immune attack that causes type 1.
Having proved effective at slowing the onset of type 1, researchers are now investigating whether teplizumab can also help people who already have type 1.
The PROTECT study took place at four sites in England and Wales. 300 young people aged between eight and 17 years, who had all been diagnosed with type 1 in the previous six weeks, took part in the study.
Approximately 217 participants were given one course of daily teplizumab injections for 12 days, then another course of injections after six months.
Meanwhile the remaining people who took part received injections in the same procedure, but theirs contained a placebo.
The researchers took the children’s C-peptide levels, which is a measure of the amount of insulin a person can make, at week 78 of the trial.
The children and adolescents who were treated with teplizumab had significantly higher C-peptide levels than those in the placebo group.
Insulin is made by cells in the pancreas called beta cells, so the results suggest that teplizumab can preserve beta cell function in people newly diagnosed with type 1.
The researchers found that the C-peptide levels of the people who received teplizumab declined more slowly than those who had the placebo.
The more beta cells a person has, the more insulin they can make. Being able to make some insulin yourself can make type 1 easier to manage and keep glucose levels more stable.
This is sometimes known as the honeymoon phase or period. Puberty and hormones can make type 1 even more difficult for young people to manage, so teplizumab could help get them through those challenging times.
Discussions are ongoing between Sanofi, the drug company that makes teplizumab, and the MHRA, the government agency that approves new drugs.
The MHRA has already given teplizumab an ‘innovation passport’, which is a way to speed up the approval process.
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