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Clinical trial finds teplizumab slows type 1 diabetes in people newly diagnosed

Results from a clinical trial called the PROTECT study show that teplizumab can preserve beta cell function in children and adolescents newly diagnosed with type 1 diabetes.
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Kate Lawton 18 October 2023

Young person receiving an injection of the immunotherapy drug teplizumab.jpg

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 today 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.

What is teplizumab?

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 clinical trial

The PROTECT study took place at four sites in Engand 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.

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.

Results of the PROTECT study

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.

Why is preserving beta cells important?

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. We know that 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.

How were JDRF involved?

We played a crucial role in funding the early research in the development of teplizumab including early tests in mice, trial recruitment networks, and the clinical trials themselves. For nearly three decades, we have been funding Professor Kevin Herold, who is a co-author of this paper on the PROTECT study and has led several other clinical trials of teplizumab.

Teplizumab in the UK

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.

To learn more about teplizumab, please see our FAQs.

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