Experimental Drug Delays Onset of Type 1 Diabetes

Maricruz Casares
Junio 12, 2019

Of those, they chose the participants who had two or more type 1 diabetes autoantibodies and abnormal blood sugar levels. Subjects were randomised to receive either PRV-031 (teplizumab) or placebo.

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).

An experimental drug was able to slow down the progression of type 1 diabetes, an inherited disease, among high-risk patients in a small clinical trial.

"Although the trial showed a marked delay in the onset of overt diabetes, the results should not be taken to imply that immune modulation constitutes a potential curative approach", the two NEJM editors wrote in an editorial also published Monday.

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 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.

"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. The drug is being developed by Provention Bio Inc. and is not yet approved by the FDA.

Annualized rates of diabetes diagnosis were 14.9% and 35.9%, respectively.

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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.

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

The study involved 76 participants aged between 8-49 years deemed to be at high risk of the condition. "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".

Jeffrey Bluestone PhD, A.W.is Mary Margaret Clausen distinguished professor of metabolism and endocrinology at the UC San Francisco (UCSF) Diabetes Center, president, CEO of the Parker Institute for Cancer Immunotherapy, and a director of Provention Bio.

About 1.25 million Americans suffer from the disease, a form of diabetes in which the pancreas stops producing essential insulin, which regulates blood sugar. 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. 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. In total, 19 (43%) teplizumab and 23 (72%) placebo patients were diagnosed with T1D. MacroGenics/Provention Bio donated the study drug and provided funds for additional site monitoring.

The share price of Provention Bio doubled yesterday after it released data which showed its immunotherapy PRV-031 (teplizumab) could delay the onset of of type 1 diabetes in children and adults by a median of two years. Provention's diversified portfolio includes advanced-stage product development candidates that have undergone clinical testing by other companies.

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