“Disease interception” introduces a paradigm shift in healthcare delivery, moving away from the standard model of “diagnose and treat” to an innovative model of “predict and pre-empt.” Dr Nicola Davies, PhD, explains how this new model applies to type 1 diabetes (T1D).
Disease interception and T1D
The diagnosis of diabetes usually follows clinically observable symptoms, but research has shown that the disease process begins long before those clinical symptoms appear. In particular, T1D manifests clinical symptoms when the body’s immune system attacks and destroys the insulin-producing beta cells of the pancreas. However, there is a significant period of time before the body’s insulin-producing beta cells are completely destroyed by the immune system — and it is during this time that the disease can be intercepted and prevented.
Progress in T1D interception
In early 2015, Janssen Research & Development LLC launched the Disease Interception Accelerator (DIA), a group focused on developing disease interception solutions. Now known as the World Without Disease Accelerator (WWDA), the first area of focus for the initiative is T1D. Working alongside JDRF, a global organization funding T1D research, several advances been made in efforts intercept T1D:
A digital twin is a virtual model of a system, product or process that perfectly mirrors all the features of its physical counterpart — including a human counterpart. Although already in use within other industries, its introduction within healthcare is relatively new and holds exciting potential. Using the digital twin of a child’s body system before and during the onset of T1D, for example, researchers will be able to identify the earliest predictors of T1D commencement and progression. Electronic medical records can be used to continuously integrate real-life data into the digital twin to ensure it continues to accurately replicate its human counterpart.
Working alongside Janssen WWDA to develop disease interception solutions is the Janssen Human Microbiome Institute (JHMI). JHMI is focused on uncovering how communities of harmful, beneficial and neutral microorganisms that make up the human microbiome can be harnessed to intercept T1D and other chronic diseases. According to the JHMI, the microbiome — which can be influenced by several factors including diet and medication — can alter the immune system. As T1D is an autoimmune disease, research is being carried out to better understand how the microbiome might influence the progression of the disease. This could have huge implications for disease interception.
JDRF has been powering groundbreaking T1D research and development of new therapies through its Immunotherapy Program. The foundation has an ambition to permanently turn off the autoimmune response that causes the deadly attack against insulin-producing beta cells. The therapies being developed through this program are specifically targeted towards disabling the overactive immune killer-cells, which destroy the insulin-producing beta cells in the pancreas, so that the body never develops T1D.
Meanwhile, the Immunosciences group of WWDA is focused on advancing research in two core areas: adaptive immunity (which is created in response to exposure to a foreign substance) and innate immunity (already present in the body). The adaptive immunity group is working to understand how antigens initiate T- and B-cell responses in autoimmune diseases, while the innate immunity group is focused on the early inflammatory responses to these autoimmune events.
Other scientific efforts underway to develop disease interception solutions for T1D include:
Provention Bio’s work on PRV-o31 (teplizumab)
The company is set to begin phase 3 trials on the drug, which has been granted Breakthrough Therapy designation by the FDA for the prevention, interception or delay of T1D. An anti-CD3 monoclonal antibody, studies have shown that compared to placebo, a single course of PRV-031 delayed the onset of T1D by a median of two years in people at high risk of developing the disease. It also proved capable of protecting the remaining beta cells in newly diagnosed T1D patients and reducing the need for external insulin dependence.
Studies on genetic and environmental triggers
Local and international studies are under way that identify and monitor children at high risk of T1D to better understand the genetic and environmental triggers of T1D — so that the disease can be detected and therefore intercepted at the earliest possible time. Although the role of environmental factors in T1D is not yet understood, it is believed that diet, vitamin D intake, infections and intestinal microbiota contribute to triggering the disease.
A medical breakthrough waiting to happen
It would be a medical breakthrough of significant proportions if the interception of T1D is successfully achieved. With so many promising scientific efforts taking place, success may not be too far off.
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