Provention Bio announces results from At Risk study in Type 1 Diabetes
Provention Bio announced that results from the National Institutes of Health-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 meeting. The "At-Risk" Study was sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases, with additional support from JDRF. The study was conducted by the Type 1 Diabetes TrialNet, an international collaboration aimed at discovering ways to delay or prevent type 1 diabetes, and evaluated Provention's PRV-031 for the prevention or delay of clinical T1D in relatives of type 1 diabetics at high-risk of developing the disease. PRV-031 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; 72% of participants were under the age of 18. Subjects were randomized to receive either PRV-031 or placebo. Results from the study showed that a single 14-day course of PRV-031 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-treated participants to clinical diagnosis of T1D was just over 48 months. During the trial, 72% in the placebo group developed clinical diabetes compared to only 43% of the PRV-031 group. PRV-031 was well tolerated and the safety data were consistent with prior studies in newly diagnosed patients.