Data from Pharmawand - Curated by EPG Health - Date added 12 June 2019

Provention Bio, Inc. announced that results from the National Institutes of Health (NIH)-sponsored "At-Risk" Study were published on-line in The New England Journal of Medicine and presented at the Scientific Sessions of the 79th Annual American Diabetes Association (ADA) meeting. The "At-Risk" Study was sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases, with additional support from JDRF (Juvenile Diabetes Research Foundation Ltd). The study was conducted by the Type 1 Diabetes TrialNet, an international collaboration aimed at discovering ways to delay or prevent type 1 diabetes (T1D), and evaluated Provention's PRV 031 (teplizumab) for the prevention or delay of clinical T1D in relatives of type 1 diabetics at high-risk of developing the disease.

PRV 031 (teplizumab) is an anti-CD3 monoclonal antibody in development for the interception and prevention of clinical T1D. The "At Risk" Study enrolled 76 participants ages 8 to 49 who were "At-Risk" because they had two or more T1D autoantibodies and abnormal glucose metabolism (dysglycemia); 72% of participants were under the age of 18. Subjects were randomized to receive either PRV-031 (teplizumab) or placebo. Results from the study showed that a single 14-day course of PRV 031 (teplizumab) significantly delayed the onset and diagnosis of clinical T1D, as compared to placebo, by a median of 2 years in children and adults considered to be at high risk. The median time to clinical diagnosis of T1D for placebo participants was just over 24 months. In comparison, the median time for PRV 031 (teplizumab)-treated participants to clinical diagnosis of T1D was just over 48 months (p=0.006). During the trial, 72% in the placebo group developed clinical diabetes compared to only 43% of the PRV 031 (teplizumab) group. PRV 031 (teplizumab) was well tolerated and the safety data were consistent with prior studies in newly diagnosed patients.


Dr. Kevan Herold, M.D., Professor of Immunobiology and Medicine at Yale University, lead author of the (At Risk) study, stated, "These results have real clinical meaning for individuals at-risk of developing clinical type 1 diabetes such as family members of patients. Delaying the onset of clinical T1D may mean the disease burden could be postponed to a point at which patients are better able to manage their disease such as after infancy, elementary school, high school or even college. With PRV 031 (teplizumab), we may now be able to intervene and fundamentally change the progression of T1D for these at-risk subjects. In addition, we look forward to learning more as we observe patients during the study's follow-up period, which will also evaluate the long-term outcomes for those in whom the diagnosis of disease has been delayed to see if they will be diagnosed with T1D or are protected."

See- "An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes"- Kevan C. Herold, M.D., Brian N. Bundy, Ph.D., S. Alice Long, Ph.D., Jeffrey A. Bluestone, Ph.D., et al., for the Type 1 Diabetes TrialNet Study Group-June 9, 2019 DOI: 10.1056/NEJMoa1902226.


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