Wednesday, 12 August, 2020

New drug may help delay onset of Type 1 diabetes, study says

IMAGE Brothers volunteer for Type 1 Diabetes TrialNet.  view more  Credit Benaroya Research Institute IMAGE Brothers volunteer for Type 1 Diabetes TrialNet. view more Credit Benaroya Research Institute
Gustavo Carr | 12 June, 2019, 04:39

The new therapy was discovered by Yale University researchers, who conducted a trial on 76 people mostly aged between 8 and 18 who had not yet developed diabetes but who had abnormal blood sugar and had family members the disease. Patients were randomized to receive either teplizumab-an Fc receptor-nonbinding anti-CD3 monoclonal antibody-or placebo; for 14 days, patients received a single daily dose.

"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".

The study, involving treatment with an anti-CD3 monoclonal antibody (teplizumab), was conducted by Type 1 Diabetes TrialNet, an global collaboration aimed at discovering ways to delay or prevent Type-1 diabetes.

"It's remarkable to see that a single course of two-week therapy cut the incidence of diabetes by nearly 50 percent during this trial".

This remained significant even after adjustment for age, baseline oral glucose tolerance test, and the presence of anti-GAD65 antibody in the phase 2 TrialNet study, Herold reported at the American Diabetes Association (ADA) annual meeting.

A two-year delay in the onset of Type 1 diabetes could make a big difference for people with the disease.

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).

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"The delay of progression to diabetes is of clinical importance, particularly for children, in whom the diagnosis is associated with adverse outcomes, and given the challenges of daily management of the condition", they wrote. With PRV-031 (teplizumab), we may now be able to intervene and fundamentally change the progression of T1D for these at-risk subjects. Previously, we could do a blood test and advise the family that their child will develop diabetes.

Teplizumab's path to this result was a long one. We are also assessing PRV-031 in newly-diagnosed T1D patients in our Phase 3 PROTECT study, which commenced in April. "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". A webcast presentation will also be available on the Investors page of the Company's website, To access the call, please dial 1-877-870-4263 (domestic) or 1-412-317-0790 (international) five minutes prior to the start time and ask to be connected to the "Provention Bio Call".

Provention Bio's approach is to intercept the T1D process at an early stage of the autoimmune condition, which involves a set of autoantibodies being created in the body which eventually destroy all the insulin cells in the pancreas.

Previous studies showed teplizumab prolonged insulin production in people recently diagnosed with Type 1 diabetes, but this is the first study to test it in people at high risk for the disease. Various factors such as age have contributed to the ability of the teplizumab to delay its clinical disease.

Commenting on the findings, Dr Clifford Rosen, who is from the Maine Medical Center Research Institute together with journal deputy editor Dr Julie Ingelfinger said: "We can finally say that there has been substantial progress in modulating the early course of type 1 diabetes".

Provention Bio Inc is developing the drug.