Drug May Help Delay Onset of Type 1 Diabetes

12 Juin, 2019, 04:38 | Auteur: Yves Courtet
  • Breakthrough type 1 diabetes drug trial delays disease after just 14 days

All study participants were relatives of people with type 1 diabetes who had two or more autoantibodies and abnormal blood sugar levels as identified by TrialNet's Pathway to Prevention study. 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.

'As anyone with type one diabetes will tell you, and particularly for children who are most commonly affected, every day you can delay this disease is important, ' said Professor Kevan Herold who led the Yale University study.

Many patients who are at risk of developing type 1 diabetes could have their disease onset delayed or even prevented by a new treatment, in what could be a remarkable breakthrough. 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.

The US study team reports this is the first time a medication has been able to delay the onset of type 1 diabetes.

Shares in the USA biotech rose 217% to $13.79 thanks to the phase 2 trial in 76 patients at risk of developing Type 1 diabetes (T1D) who were given PRV-031 significantly delayed the onset and diagnosis of Type 1 diabetes compared to placebo, by a median of 2 years in children and adults considered to be at high risk. 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. With PRV-031 (teplizumab), we may now be able to intervene and fundamentally change the progression of T1D for these at-risk subjects.

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 new study was conducted through Type 1 Diabetes TrialNet, a large research network that includes Stanford, although Stanford was not a treatment site for this particular project. "The rate of development of diabetes was reduced by half".

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

Provention Bio said, based on the results, it's evaluating a regulatory path for PRV-031 at risk-patients. We are also assessing PRV-031 in newly-diagnosed T1D patients in our Phase 3 PROTECT study, which commenced in April. 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".

Type-1 diabetes develops when the immune system's T cells mistakenly destroy the body's own insulin-producing beta cells. 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.

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.

Type 1 diabetes is an autoimmune disease with a genetic component. 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. Meanwhile, only 43 percent of participants in the teplizumab group developed the disease.

According to the developer of the drug Provention Bio Inc, it is necessary to conduct additional, more extensive studies before registering teplizumab as a drug.

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