Researchers Discover a Breakthrough Drug That May Significantly Delay Type 1 Diabetes

Grant Boone
June 12, 2019

PRV-031 (teplizumab) is an anti-CD3 monoclonal antibody in development for the interception and prevention of clinical T1D.

Slowing the progression to type 1 diabetes in at-risk teens and young adults - who made up the majority of study participants - is significant because the risk of disease decreases with age.

Nineteen of the 44 individuals given teplizumab went on to become diabetic, compared to 23 of the 32 who received placebo. One group was assigned to take the experimental drug teplizumab over the course of 14 days.

In the 60 months following randomization, only 43% of those who received teplizumab were diagnosed with type 1 diabetes compared with 72% of those who received placebo.

The drug was well tolerated and the safety data were consistent with prior studies in newly diagnosed 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.

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The first year after teplizumab therapy yielded the largest benefit for patients, reducing the risk for developing type 1 diabetes by 87% compared with the saline placebo (unadjusted HR 0.13, 95% CI 0.05-0.34).

All participants regularly received glucose tolerance tests until the study was completed, or until they developed clinical Type 1 diabetes - whichever came first. In light of the daily burden of disease management, any time without clinical diabetes has significance.

"But it's particularly an issue for children, who represent about three-quarters of the participants in our study", he stated. The theme of this year's Diabetes Week is to "See Diabetes Differently" as everyone is different, and we want everyone to see diabetes differently. "We will not waver in our mission to eradicate type 1 diabetes".

Additional studies will be required before regulatory agencies approve the drug. "We are delighted with the results, which reinforce our confidence not only in PRV-031 (teplizumab), but in Provention's strategic intent to intercept and prevent immune-mediated disease. We've had trials that have been going on for a couple of decades, but they have not been able to prevent diabetes", declared Kevan Herold, a professor of immunology and endocrinology at Yale University and the lead author of the study. Those given the drug developed the autoimmune disease in an average of 48 months. A webcast presentation will also be available on the Investors page of the Company's website, www.proventionbio.com.

Type 1 diabetes is a condition where your blood glucose level is too high because your body can't make a hormone called insulin. 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. "Some interventions have delayed the loss of insulin production in patients with type 1 diabetes, but interventions that might affect clinical progression before diagnosis are needed". 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. MacroGenics/Provention Bio donated the study drugs and provided funds for additional site monitoring.

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