Critical Path’s New Initiative to Halt Type 1 Diabetes

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A non-profit organization called the Critical Path Institute is spearheading a new initiative called the Type 1 Diabetes Consortium (T1D Consortium) focused on research to slow and halt the progression of type 1 diabetes.

The Consortium is supported by The Leona M. and Harry B. Helmsley Charitable Trust, Janssen Research & Development, LLC, JDRF International, and Sanofi. Its work will focus on developing innovative therapies for the treatment, and ultimately the prevention, of type 1 diabetes.

According to their website, “Critical path is dedicated to bringing scientists from the FDA, industry and academia all together to collaborate and improve the drug development and regulatory process for medical products.”

The specific focus of the T1D Consortium’s research will be to “qualify islet autoimmunity antibodies as prognostic biomarkers.”

“Achieving regulatory qualification of these antibodies as biomarkers will lead to better clinical trial design and more accurate identification of individuals who would likely benefit from early intervention,” said President and CEO of Critical Path, Dr. Martha Brumfield.

Critical Path notes that the presence of certain autoantibodies combined with tracking blood glucose levels allows scientists to separate type 1 diabetes into three stages. (In 2015 JDRF and the American Diabetes Association, supported by other organizations in the field, put forth a new staging system for type 1 diabetes.) In stage 1, despite normal blood glucose levels, autoantibodies can be detected in patients. The same autoantibodies are present in stage 2, but unsteady or irregular blood glucose levels are identified. By the time a patient reaches stage 3, the autoantibodies are present and blood glucose levels are high enough to indicate diabetes.

Being able to diagnose diabetes early—before precipitous loss of beta cells catapults someone into full-blown disease—is important for a few reasons. Right now, many children (46%, according to one study, of children in Colorado) are not diagnosed until they’re in DKA (diabetic ketoacidosis), a condition that is fatal if not caught in time. The later in the disease process someone is diagnosed, the more beta cells have already been destroyed. One of the things researchers are interested in is whether having more beta cells at diagnosis leads to better outcomes in terms of glucose control and long-term complications from the disease.

The hope of the T1D Consortium is to be able to understand more about the early stages of Type 1 diabetes so as to be able to intervene sooner and, ideally, to stop the progression of the condition completely.

Dr. Jessica Dunne, Director of Discovery Research at JDRF said about the new Consortium, “We will apply these biomarkers together with the staging approach to design new clinical trials, conduct the trials more effectively, and ultimately, develop interventions to arrest progression to symptomatic type 1 diabetes.”

According to the diabetes magazine ASweetLife, “someone who tests positive for one autoantibody may never develop the disease, someone with multiple autoantibodies has a lifetime risk of 100%.” The more autoantibodies that are present, the more aggressive the autoimmune destruction is and the faster the rate of progression. Another factor in speed of progression is the age you are at the onset of autoantibodies, or stage 1. In other words, while a very young child might progress from stage 1 to stage 3 in a matter of months, an adult might progress over a period of years or decades.

JDRF has already spent years focusing on prevention research, including genetic research to stop the body from developing cells that attack and destroy insulin producing cells, also known as beta cells, and secondary prevention research looking at ways to retrain the immune system and/or protect beta cells.

In 2011, Selecta Sciences collaborated with JDRF and Sanofi to develop a vaccine to stop the autoimmune attack that causes Type 1 diabetes. That partnership was extended in 2014, and now JDRF and Sanofi are working together again as part of this new initiative.

The Consortium will also be working with INNODIA, a European-based, public-private partnership. INNODIA also works to better understand type 1 diabetes and “to pave the way to novel therapeutic options to prevent and cure T1D.”

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rick phillips

Sounds like this effort needs to check in with trialnet.

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