Type 1 Diabetes (T1D) is a autoimmune genetic disease that results in a person’s pancreas not making enough insulin to sustain themselves. Insulin helps the sugar from a meal enter your body's cells to be broken down into energy for the body to use. Without insulin, your body is not absorbing any sugar, nor is it breaking down sugar to create energy. Potential complications of untreated Type 1 diabetes include heart disease, kidney problems, delayed wound healing, eye problems, and more.
Type 1 Diabetes is usually diagnosed between the ages of 8-17. These days, most T1D patients have a blood glucose monitor which measures the levels of sugar in their blood, detects when it is low/high, and the patient can adjust accordingly (eat something if it is low, or inject insulin if high.) Treatment with insulin is important to prevent diabetes from progressing to affect other organs of the body. See the video below for more information about T1D.
Those who are at risk of potentially developing T1D can get tested via testing for pancreatic autoantibodies, which signals the fact there is some sort of autoimmune disorder in the pancreas damaging β-cells. At this point where autoantibodies are detectable, many patients can be unaware they even have diabetes since they are asymptomatic. This is where Provention Bio comes in with their new drug.
Provention Bio recently got FDA approval for their new drug, teplizumab known as Tzield. Teplizumab is a monoclonal antibody (mab) that acts as an Fc receptor–nonbinding anti-CD3 monoclonal antibody. Teplizumab is for those patients mentioned earlier with autoantibodies but not quite at the stage that they are presenting with clinical signs of T1D. Teplizumab was tested by having a study done on 76 participants at high-risk of developing T1D. 44 patients got teplizumab, and 32 patients got placebo. Ultimately, they saw that teplizumab did indeed slow down the development of T1D. There were more T1D diagnoses in the placebo group than in the treatment group. This ultimately means that the drug was indeed successful in delaying the onset of T1D.
Tzield is the first drug of its sort - all the drugs we currently have for T1D only work after the symptoms have started and the diagnosis of T1D is made. It is exciting to finally see a potential drug that could delay the onset of T1D, and this may be the first drug in a class of drugs with the potential to eliminate T1D overall.
References
1 K.C. Herold, B.N. Bundy, S.A. Long, J.A. Bluestone, L.A. DiMeglio, M.J. Dufort, et al.
An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes N. Engl. J. Med., 381 (7) (2019), pp. 603-613
2 https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-can-delay-onset-type-1-diabetes
3 Diane K. Wherrett, Jane L. Chiang, Alan M. Delamater, Linda A. DiMeglio, Stephen E. Gitelman, Peter A. Gottlieb, Kevan C. Herold, Daniel J. Lovell, Trevor J. Orchard, Christopher M. Ryan, Desmond A. Schatz, David S. Wendler, Carla J. Greenbaum, the Type 1 Diabetes TrialNet Study Group; Defining Pathways for Development of Disease-Modifying Therapies in Children With Type 1 Diabetes: A Consensus Report. Diabetes Care 1 October 2015; 38 (10): 1975–1985. https://doi.org/10.2337/dc15-1429