A single course of Provention’s PRV-031 (teplizumab) has been found to delay type I diabetes onset in high-risk individuals by at least two years.
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 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.
A single 14-day course of PRV-031 was found to significantly delayed the onset and diagnosis of clinical type I diabetes, as compared to placebo, by a median of two years in children and adults considered to be at high risk.
The median time to clinical diagnosis of type I diabetes for placebo participants was just over 24 months, compared to 48 months in PRV-031 (teplizumab)-treated participants.
The drug was well tolerated and the safety data were consistent with prior studies in newly diagnosed patients.
The groundbreaking study “demonstrates that we can use immunotherapy, specifically PRV-031, to prevent or significantly delay the onset of clinical type 1 diabetes by at least two years in individuals who will almost certainly progress to clinical disease,” said Dr. Eleanor Ramos, Provention’s chief medical officer and chief operating officer.
“More importantly, approximately 60% of subjects in the study did not develop type I diabetes following only one course of PRV-031 therapy, double the placebo group. Teplizumab is the first immune modulator to show a delay in the clinical onset of type 1 diabetes.”
The treatment is an anti-CD3 monoclonal antibody (mAb), which is being developed for the interception and prevention of type I diabetes and has been the subject of multiple clinical studies involving more than 1,000 subjects with more than 800 patients.