Drug Targeting Immune System Delays Type 1 Diabetes in High Risk Patients

Immunotherapy delays type 1 diabetes in people at high risk

The study, involving treatment with an anti-CD3 monoclonal antibody (teplizumab), was conducted by Type 1 Diabetes TrialNet, an worldwide collaboration aimed at discovering ways to delay or prevent Type-1 diabetes. All participants received glucose tolerance tests regularly until the study was completed, or until they developed clinical Type-1 diabetes - whichever came first. Each year, the rate of type 1 diabetes diagnosis was about 36% in the placebo group versus 15% in the teplizumab group. In the control group, the average time for the people to evolve clinical diabetes was just 24 months, whereas the people who developed diabetes in the treatment group had a moderate point of 48 months, before the process of diagnosing.

Provention said in a statement it would evaluate a regulatory path forward for the drug, which entered Phase 3 testing among newly-diagnosed Type 1 diabetes in April. "The 2-year delay in diagnosis is clinically important".

TrialNet Chair Dr Carla Greenbaum, Director of the Diabetes Research Program at Benaroya Research Institute in Seattle, said: "In addition to being able to accurately predict who will develop T1D, we have now found a way to delay it".

"The results of this trial are striking, with several caveats", wrote two NEJM editors in a related editorial, cautioning against interpreting the study as evidence immune modulation could be potentially curative. Most participants had a sibling with type 1 diabetes.

The study involved 76 participants aged between 8-49 years deemed to be at high risk of the condition. The most common autoantibodies were harmonized anti-GAD65, followed by anti-ZnT8, harmonized anti-IA-2, ICA, and micro insulin. The research is the first to show that the progression of type 1 diabetes can be slowed by two or more years with immunotherapy.

All included individuals had dysglycemia prior to the study, marked by a fasting glucose between 110-125 mg/dL, a 2-hour post-prandial plasma glucose ≥140-200 mg/dL, or an intervening postprandial glucose levels 200 mg/dL at two occasions.

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Teplizumab works by binding to the pro-inflammatory T cell co-receptor CD3, which in turn prevents them from activating the T cells that attack and kill the pancreas' beta cells. This intravenous infusion was given as a 51 µgram/m of body-surface area on at day 0. Through a 14-day treatment regimen, patients administered teplizumab received increasing doses until day 4.

"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".

Teplizumab was associated with some adverse events (AE), with 112 events occurring in the study arm versus 23 events reported with placebo. A total of 75% of participants who received teplizumab experienced a form of AE relating to blood or bone marrow, such as transient lymphopenia. But we also want to prevent this condition ever developing in those at risk. "Teplizumab is the first immune modulator to show a delay in the clinical onset of type 1 diabetes".

Rosen and Ingelfinger said questions remain regarding this therapy, such as long-term side effects, the frequency and duration of treatments needed for the best effect, and separating treatment responders from non-responders. The trial was financed by the National Institutes of Health and the Juvenile Diabetes Research Foundation.

Then, last spring, New Jersey-based Provention Bio reached a deal with MacroGenics to acquire the rights to the drug, betting on its potential to halt immune attacks on beta levels.

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