This remained significant even after adjustment for age, baseline oral glucose tolerance test, and the presence of anti-GAD65 antibody in the phase 2 TrialNet study, Herold reported at the American Diabetes Association (ADA) annual meeting.
The US biotech firm was established just three years ago, and acquired rights to teplizumab from MacroGenics, which suspended its development of the drug in 2010 after a clinical trial run with Lilly showed it failed to show sufficient efficacy in T1D patients.
"This groundbreaking study demonstrates that we can use immunotherapy, specifically PRV-031 (teplizumab), to prevent or significantly delay the onset of clinical type 1 diabetes by at least two years in individuals who will nearly certainly progress to clinical disease", said Dr. Eleanor Ramos, Provention's chief medical officer and chief operating officer.
Previous studies showed teplizumab prolonged insulin production in people recently diagnosed with Type 1 diabetes, but this is the first study to test it in people at high risk for the disease.
A treatment affecting the immune system effectively slowed the progression to clinical type 1 diabetes in high risk individuals, according to findings from National Institutes of Health-funded research. The risk of Type-1 diabetes among children and adolescents is growing faster than adults.
Among the control group, 72 percent of patients were diagnosed with clinical diabetes during the study period. "The results have important implications for people, particularly youth, who have relatives with the disease, as these individuals may be at high risk and benefit from early screening and treatment". The median time to diagnosis in the teplizumab group was almost twice that of the placebo group (48.4 months vs. 24.4 months). Various factors such as age have contributed to the ability of the teplizumab to delay its clinical disease.
PRV-031, also known as teplizumab, is an anti-CD3 monoclonal antibody (mAb), which is being developed for the interception and prevention of type 1 diabetes (T1D). Participants who responded to teplizumab tended to have certain autoantibodies and other immune system characteristics.
"While the results are encouraging, more research needs to be done to address the trial's limitations, as well as to fully understand the mechanisms of action, long-term efficacy and safety of the treatment", said Dr. Spain.
"It's a very interesting step forward for the field", Wilson said. For more information, visit http://www.trialnet.org. Additional support comes from JDRF and the American Diabetes Association. "We will not waver in our mission to eradicate type 1 diabetes".
Provention Bio, Inc. (Nasdaq:PRVB) is a clinical-stage biopharmaceutical company leveraging a transformational drug development strategy that is focused on the prevention or interception of immune-mediated disease.
The researchers conducted their trial on 76 patients, mostly aged between eight and 18.
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.