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Peptide Immunotherapy Shown Safe for Type 1 Diabetes

Diabetes items

(Centers for Disease Control and Prevention)

10 August 2017. In an early clinical trial, researchers in the U.K. show treatments with peptides, fragments of proteins, are safe and can slow the progression of type 1 diabetes. A team from King’s College London and Cardiff University in Wales describe their findings in yesterday’s issue of the journal Science Translational Medicine.

Type 1 diabetes is an inherited autoimmune disorder where the body does not produce insulin, and is diagnosed primarily in children or young adults. Autoimmune disorders are conditions where the immune system is tricked into attacking healthy cells and tissue as if they were foreign invaders, in this case, insulin-producing beta cells in the pancreas. About 1.25 million people in the U.S. and 400,000 in the U.K. have type 1 diabetes, about 5 percent of people with diabetes of any kind.

With no therapies for type 1 diabetes yet approved, the research team led by King’s College immunologist Mark Peakman is seeking a way of using immunotherapies to treat the disorder. Immunotherapies harness the immune system to fight disease and are being developed for a number of conditions. But with autoimmune diseases like type 1 diabetes, there’s a risk of making the patient’s condition worse by triggering an unintended immune system reaction.

Peakman’s lab is developing an immunotherapy for type 1 diabetes in the form of peptides, or short protein fragments, which were tested in the trial. This peptide is a proinsulin, or precursor to insulin, produced in the pancreas’s beta cells with genetic markers similar to people with type 1 diabetes. The goal, as Peakman explains in a Kings College statement, is to harness and protect the still-functioning beta cells. “When someone is diagnosed with type 1 diabetes they still typically have between 15 percent and 20 percent of their beta cells,” says Peakman. “We wanted to see if we could protect these remaining cells by retraining the immune system to stop attacking them.”

The early-stage clinical trial recruited 24 individuals with type 1 diabetes at 5 sites in the U.K., diagnosed in the previous 100 days, and who had the specific genetic markers associated with the proinsulin peptide. Participants were randomly assigned to receive injections of the peptide every 2 weeks for 6 months, peptide injections every 4 weeks for 6 months alternating with saline solution injections between the peptide injections, or only saline solution injections every 2 weeks for 6 months.

The study team look primarily at safety factors, notably any damage to participants’ remaining beta cells, as well as allergic and injection site reactions. The researchers found recipients of the peptide injections every 2 or 4 weeks had no reductions in C-peptides associated with insulin production, indicating their functioning beta cells remained stable over the 6 months. Among participants receiving the saline solution, however, their insulin production declined during this period. Over 12 months, daily insulin use by peptide recipients remained stable, while saline solution recipients increased their daily insulin by 50 percent.

The researchers found the peptide injections were well tolerated with no systemic or local site reactions. In addition, the immune systems in peptide recipients continued to function and even improve protective T-cell responses, with no additional stress put on beta cells.

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

Kings College licensed the technology for type 1 diabetes to biopharmaceutical company UCB in Brussels that plans to commercialize the peptide and develop a next-generation product for further clinical trials.

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