This Treatment May Delay T1D Diagnosis in High-risk Patients

Modesto Morganelli
Giugno 12, 2019

According to the data collected, in the group of people receiving Teplizumab, type 1 diabetes developed one year later than those who received placebo: 7% of people who received the experimental drug were diagnosed with diabetes in the first year after starting therapy, while as in the placebo group, this figure was 44%.

She said: "In Milton Keynes there are 13,971 people who have been diagnosed and are living with diabetes, and it is thought that more than half of all cases of Type 2 diabetes could be prevented or delayed with the early identification of people at risk of developing it in the future".

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. A Phase 3 study of teplizumab in diabetes patients with recent-onset disease failed in 2010, and Lilly handed back its rights to the drug to MacroGenics. "This discovery is the first evidence we've seen that clinical type 1 diabetes can be delayed with early preventive treatment", said Lisa Spain, a project scientist at the National Institute of Diabetes and Digestive and Kidney Diseases, in a press release.

"More importantly, approximately 60% of subjects in the study did not develop type I diabetes following only one course of PRV-031 therapy, double the placebo group". He said: "After repeated failures, this is the first time anyone's been able to delay the onset of type 1 diabetes". Their glucose tolerance was tested at regular intervals throughout the trial or until they developed type 1 diabetes. In light of the daily burden of disease management, any time without clinical diabetes has significance. With PRV-031 (teplizumab), we may now be able to intervene and fundamentally change the progression of T1D for these at-risk subjects. "Having an understanding of diabetes is key to helping people live better, and that's why we are celebrating Diabetes Week all week and by sharing the Diabetes UK "Five Facts of Diabetes" to help reach as many people as possible".

Jeffrey Bluestone, a distinguished diabetes researcher and a director of Provention Bio had worked on the drug for over 30 years, and was instrumental in in-licensing.

The TrialNet research has been funded by the US National Institutes of Health (NIH), primarily through the Special Diabetes Program, with additional support from JDRF.

The study included 76 people older than 8 years.

Provention Bio said, based on the results, it's evaluating a regulatory path for PRV-031 at risk-patients.

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. "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".

Type 1 diabetes occurs when the body's immune system mistakenly attacks insulin-producing cells called 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 allows the glucose in our blood to enter our cells and fuel our bodies. 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.

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