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Immunotherapy shown to be safe in people with Type 1

10 August 2017

Researchers at King’s College London, supported in part by Diabetes UK, and Cardiff University have shown that a peptide immunotherapy is safe to use in people with Type 1 diabetes.

Type 1 diabetes develops when the immune system goes rogue and starts attacking insulin-producing beta cells in the pancreas, until all or most of the beta cells are destroyed.

Peptide immunotherapy relies on injecting small protein fragments (or peptides) to ‘retrain’ the immune system and stop it attacking the pancreas, potentially preventing or slowing down Type 1 diabetes.

How do immunotherapies work?

Earlier research has shown that ‘immunosuppressant’ drugs (similar to those used after an organ transplant) weaken the immune attack in Type 1 diabetes. This helps to prevent the destruction of insulin-producing beta cells and can lead to short-term improvements in blood glucose control.

But if the whole immune system is weakened, people are more vulnerable to infections and cancer. So researchers are working to selectively target parts of the immune system thought to be directly responsible for the attack in Type 1 diabetes.

This MonoPepT1De study was designed to see if peptide immunotherapy is safe and to study its effect on the immune system in people with Type 1 diabetes.

During the study, participants were injected with small fragments of proteins that are recognised and attacked by the immune system in Type 1 diabetes. In this way, researchers hope to desensitise the immune system to these specific proteins, slowing down the attack against beta cells.

Exciting first step

The main purpose of the trial was to test the new treatment for safety, but researchers also observed some positive effects of peptide immunotherapy.

People receiving the treatment needed less insulin, suggesting they could still make some of their own. But the effectiveness of the treatment will have to be tested in future trials with more participants and longer duration.

Professor Mark Peakman, lead author of the study, said: “When someone is diagnosed with Type 1 diabetes they still typically have between 15 and 20 per cent of their beta cells. We wanted to see if we could protect these remaining cells by retraining the immune system to stop attacking them.”

“We still have a long way to go, but these early results suggest we are heading in the right direction. The peptide technology used in our trial is not only safe for patients, but it also has a noticeable effect on the immune system.”

Dr Elizabeth Robertson, Director of Research at Diabetes UK, said: “Diabetes UK is committed to increasing our understanding of the immune attack in Type 1 diabetes and finding ways to stop it. These new findings are an exciting step towards immunotherapies being used to prevent this serious condition from developing in those at high risk, or stop it from progressing in those already diagnosed.”

“This research is still in the very early stages, but the discovery that peptide immunotherapy is safe to use in people with Type 1 diabetes is a significant moment in our fight for a world where diabetes can do no harm.”

More research

This was a Phase I clinical trial. This means that the main purpose was to test different doses, find out if the therapy is safe, and check it doesn’t have any big adverse effects.

This trial involved 27 people with Type 1 diabetes who were within the first 100 days of their diagnosis. They were either receiving placebo (dummy) injections every two weeks, peptide injections every two weeks, or peptide injections every four weeks, over the course of six months. Since the peptide was safe to use, the next step would be a Phase II clinical trial, to evaluate if the treatment is effective at preventing the progression of Type 1 diabetes.

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