New Drug May Delay Onset of Type 1 Diabetes for Years

Breakthrough for diabetes treatment as it emerges immune system drug can delay onset of the illness

Breakthrough for diabetes treatment as it emerges immune system drug can delay onset of the illness

Of those, they chose the participants who had two or more type 1 diabetes autoantibodies and abnormal blood sugar levels. Patients were randomized to receive either teplizumab-an Fc receptor-nonbinding anti-CD3 monoclonal antibody-or placebo; for 14 days, patients received a single daily dose.

"More importantly, approximately 60% of subjects in the study did not develop T1D following only one course of PRV-031 therapy, double the placebo group".

"This is the first study to show any drug can delay Type 1 diabetes diagnosis a median of two years in people at high risk", said study lead author Dr. Kevan Herold, a Yale University professor, in a news release from the school. The theme of this year's Diabetes Week is to "See Diabetes Differently" as everyone is different, and we want everyone to see diabetes differently. All participants were tracked to see if they developed Type 1 diabetes over the next few years.

"Rather, these data provide strong albeit indirect evidence about the pathogenesis of beta-cell destruction and the potential to modify the course of type 1 diabetes with newer biologic agents", they commented, adding that this particular trial "will probably prompt the development of more refined screening criteria for treatment of persons at highest risk, although challenges in using immune modulators for type 1 diabetes remain". "We will not waver in our mission to eradicate type 1 diabetes".

Further studies will now be required to test the drug before it is approved.

The TrialNet research has been funded by the US National Institutes of Health (NIH), primarily through the Special Diabetes Program, with additional support from JDRF. "We are delighted with the results, which reinforce our confidence not only in PRV-031 (teplizumab), but in Provention's strategic intent to intercept and prevent immune-mediated disease".

Provention Bio said, based on the results, it's evaluating a regulatory path for PRV-031 at risk-patients. Those given the drug developed the autoimmune disease in an average of 48 months.

Jeffrey Bluestone PhD, A.W.is Mary Margaret Clausen distinguished professor of metabolism and endocrinology at the UC San Francisco (UCSF) Diabetes Center, president, CEO of the Parker Institute for Cancer Immunotherapy, and a director of Provention Bio. To access the call, please dial 1-877-870-4263 (domestic) or 1-412-317-0790 (international) five minutes prior to the start time and ask to be connected to the "Provention Bio Call".

When the immune systems T-cells falsely destroyed the insulin-producing beta cells of an individual's body, Type-1 diabetes develops in the body. The candidate has been the subject of multiple clinical studies involving more than 1,000 subjects with more than 800 patients receiving PRV-031 in those studies. This is most likely due to its effectiveness in delaying type 1 diabetes. "Some interventions have delayed the loss of insulin production in patients with type 1 diabetes, but interventions that might affect clinical progression before diagnosis are needed". Various factors such as age have contributed to the ability of the teplizumab to delay its clinical disease. Meanwhile, only 43 percent of participants in the teplizumab group developed the disease. MacroGenics/Provention Bio donated the study drug and provided funds for additional site monitoring. Provention's diversified portfolio includes advanced-stage product development candidates that have undergone clinical testing by other companies.

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