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‘Trojan horse’ Type I diabetes drug that could halt disease progression undergoes clinical trials at Addenbrooke’s in Cambridge

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Clinical trials that could change the future of diabetes treatment are under way at Addenbrooke’s, writes Alex Spencer.

It is one of 12 NHS hospitals involved in the Impact study of an immunotherapy that interferes early in the progression of the disease and could offer a potential cure or long-term partial cure that delays the need for Type I diabetes therapy.

The research will evaluate the effect on the preservation of beta-cell function in adult patients with the condition.

Professor Mark Evans, Impact study (57139222)
Professor Mark Evans, Impact study (57139222)

The therapy has already been proved safe, and positive biomarker data has been reported from an interim analysis of a phase II study of the drug, a proinsulin-derived Imotope known as IMCY-0098.

Prof Mark Evans is hoping to attract patients to take part in the research at Addenbrooke’s in Cambridge.

He said: “Type I diabetes makes up for 10 to 15 per cent of diabetes cases. We know it can come on at any age, and that people are dependent for their lifetime on insulin injections or infusions. It’s quite a demanding condition to live with.

“What we’re now realising is that although the onset of Type I diabetes clinically can be very sudden, it actually builds up over time, and there are a series of stages leading up to it. Even after people are diagnosed with diabetes and need insulin, they have still got a little bit of their own insulin production left.”

The study wants to recruit patients within six weeks of their Type I diabetes diagnosis but, longer term, Prof Evans hopes to be able to find people who have not yet been diagnosed, who are displaying typical symptoms of thirst or increased urination.

Recruiting patients at an early stage will help, it is hoped, preserve their remaining insulin production.

Type I diabetes is caused by an immune system attack on insulin-producing cells and the progression, Prof Evans explained, “finally reaches a tipping point, when people are no longer able to secrete enough insulin, which is the hormone in the body that helps control blood glucose and so people then flip over into having diabetes”.

He added: “In the last five years or so, we have seen an explosion of studies looking at trying to target the immune system in people with newly-diagnosed Type I diabetes and even taking one step back to find people before they have crossed the threshold, to try to slow down or delay the progression onto clinical diabetes.”

The trial at Addenbrookes is of what Prof Evans described as “a very specific and very clever type of drug developed by a small biotech company in Belgium”.

Monitoring Type I diabetes
Monitoring Type I diabetes

“The best way to describe it is as a sort of Trojan horse approach,” he continued. “So it effectively identifies and flips the culprit immune cells into destroying themselves.”

He acknowledged that finding patients within six weeks of diagnosis could prove challenging.

“What we’re trying to find is people who still have some of their own insulin production, but on a downward trajectory. We’re trying to find people who have enough of it where it makes sense to hang onto it. There are some people who already have very low levels of residual insulin secretion even at the time when they’re diagnosed.

“So we’re not turning the clock back, but what we are doing is trying to hang onto this small number of insulin-producing cells. This is unlikely to mean that in these particular studies that these people won’t have diabetes any more. But we’ve got lots of data suggesting that if people still have a little bit of their own insulin production, the risks are reduced in terms of some of the long-term problems with diabetes.”

Incidence of Type I diabetes is rising at an alarming rate of about four per cent per year.

Like much of the rest of the world, the UK is facing a diabetes crisis. With diagnoses having doubled in the last 15 years, the number of people living with any form of the disease has hit an all-time high.

Read more: Team at Addenbrooke’s in Cambridge shows babies with type I diabetes can be treated with artificial pancreas

Although Type I diabetes can appear at any age, it frequently arises in childhood, with approximately 290,000 of the 400,000 patients diagnosed in the UK being children.

Whereas Type II diabetes can relate to unhealthy lifestyle choices and a poor diet, and the risk increases with age, Type 1 diabetes is not associated with any of the same triggers. Instead, it is an autoimmune condition where insulin is not produced in our bodies.

A diabetes patient monitoring their levels
A diabetes patient monitoring their levels

That means burdensome round-the-clock self-management including a strict diet, frequent, close monitoring of blood glucose levels, along with lifelong daily insulin injections.

Novel treatments that allow people a break from the continuous cycle and tackle the impending diabetes crisis are urgently needed.

In the UK alone, 1,500 children and 1,500 adults are newly diagnosed with Type I diabetes every year, but fewer than 30 take part in a clinical trial.

Many more are needed, since one early-stage clinical trial to test the safety of a new drug could require all 30 of those people – and each later trial would then need a growing number of people to get involved.

For more information on the latest trial, visit type1diabetesresearch.org.uk/current-trials/impact-study/.

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