"Scientists have conducted a number of studies trying to prevent Type 1 diabetes or delay the progression of the disease in people who are newly diagnosed", said Darrell Wilson, MD, a pediatric endocrinologist at Stanford who is a co-author of the study. PRV-031 (teplizumab) is an anti-CD3 monoclonal antibody in development for the interception and prevention of clinical T1D. Risk status was determined due to having relatives with the condition and tests revealing autoantibodies relating to type 1 diabetes as well as higher than normal blood glucose levels.
Nineteen of the 44 individuals given teplizumab went on to become diabetic, compared to 23 of the 32 who received placebo. Those in the teplizumab group had a median time of 48 months.
During the trial, 72 per cent of the people in the control group developed clinical diabetes, compared to only 43 per cent of the teplizumab group.
"More importantly, approximately 60% of subjects in the study did not develop T1D following only one course of PRV-031 therapy, double the placebo group".
"After repeated failures, this is the first time anyone's been able to delay the onset of type 1 diabetes", chief author Dr. Kevan Herold of Yale University in New Haven, Connecticut told Reuters Health by phone.
All participants regularly received glucose tolerance tests until the study was completed, or until they developed clinical Type 1 diabetes - whichever came first. However, the medicine had never been tested in the people who did not have clinical disease. With PRV-031 (teplizumab), we may now be able to intervene and fundamentally change the progression of T1D for these at-risk subjects.
VUMC was the largest contributor to the study, providing more than 20% of the participants. This stopped diabetes developing for around two years. "The rate of development of diabetes was reduced by half".
It's at least a few years until this drug could possibly be approved for use outside of a clinical trial, said Jessica Dunne, senior director of research at JDRF (formerly the Juvenile Diabetes Research Foundation).
Teplizumab's path to this result was a long one. The asset is also now being evaluated in a Phase 3 study, dubbed PROTECT, in newly-diagnosed T1D patients. "Our broader goal for PRV-031 is to address the continuum of T1D and provide therapeutic options for this life-impacting and life-threatening autoimmune disease that, until now, has seen no disease-modifying innovation since the development of insulin a century ago".
Provention Bio will discuss these results via conference call on Monday, June 10, 2019 at 8:30 AM ET. A webcast presentation will also be available on the Investors page of the Company's website, www.proventionbio.com.
Type 1 diabetes is now considered an autoimmune condition, spurred by the destruction of insulin-producing beta cells in the pancreas. The candidate has been the subject of multiple clinical studies involving more than 1,000 subjects with more than 800 patients receiving PRV-031 in those studies. Insulin is needed to convert glucose into energy. Various factors such as age have contributed to the ability of the teplizumab to delay its clinical disease.
According to the developer of the drug Provention Bio Inc, it is necessary to conduct additional, more extensive studies before registering teplizumab as a drug.