Health Care

New drug to delay progression of Type-1 diabetes by two years

New drug to delay progression of Type-1 diabetes by two years”

A drug that targets the immune system can delay the onset of type 1 diabetes in people at high risk of developing the disease, said a Yale investigator who led the National Institutes of Health-funded Diabetes TrialNet study. PRV-031 (teplizumab) is an anti-CD3 monoclonal antibody in development for the interception and prevention of clinical T1D.

The study included 76 people, both children and adults, who had several risk factors for Type 1 diabetes: They had a relative with the disease, had at least two varieties of destructive autoantibodies in their blood, and had an abnormal metabolic response to a test that measures the body's ability to process large amounts of sugar.

Hazard ratio for T1D diagnosis in teplizumab participants was.41 (95% CI:.22 -.78; P=.006) versus placebo, and annualized diagnosis rates were just 14.9% in teplizumab versus 35.9% in placebo. The team also found that a much smaller percentage of individuals in the treatment group, 43%, developed type 1 diabetes compared to 72% in the placebo group.

"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. Until the completion of the study, all the participants have regularly received clinical Type-1 diabetes or glucose tolerance tests. The participants were tested to have diabetes-related autoantibodies, which attack the pancreas, and unhealthy blood sugar levels, which make them at high risk of developing the disease. With PRV-031 (teplizumab), we may now be able to intervene and fundamentally change the progression of T1D for these at-risk subjects.

The results were even more impressive for a subgroup of patients, around 60%, who did not develop the condition at all in the study period. "The rate of development of diabetes was reduced by half". These data clearly tell us short-term immunotherapy can significantly slow down clinical onset of diabetes.

TrialNet researchers will conduct additional studies to look for ways to extend the benefits of teplizumab.

Teplizumab's path to this result was a long one.

The company recently initiated a phase 3 trial in patients with T1D, with enrolment to be completed in 2020, and complettion scheduled for May 2022. Those given the drug developed the autoimmune disease in an average of 48 months.

At publication time, Provention Bio shares were skyrocketing 328 percent to $18.63. A webcast replay of the call will be available beginning at 11:00 AM ET on the day of the call.

"Our findings support the notion that type 1 diabetes is a chronic T-cell-mediated disease and suggest that immunomodulation before the development of clinical disease can be useful". 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. And they'll need to get better at identifying high-risk individuals who lack close relatives with Type 1 diabetes, he said. Provention is now evaluating PRV-031 in patients with recent onset T1D (the Phase 3 PROTECT Study); additional information on the clinical trial is available at clinicaltrials.gov.

Provention Bio Inc is developing the drug. The research is the first to show that the progression of type 1 diabetes can be slowed by two or more years with immunotherapy.



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