Diabetes breakthrough: Experimental drug delays type 1 condition by years

Henrietta Strickland
June 12, 2019

(Nasdaq:PRVB), a clinical stage biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced that results from the National Institutes of Health (NIH)-sponsored "At-Risk" Study were published on-line in The New England Journal of Medicine and presented at the Scientific Sessions of the 79th Annual American Diabetes Association (ADA) meeting. These individuals may occur at high risk and can get benefit from early treatment and screening.

Shares in the United States 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. "In addition, we look forward to learning more as we observe patients during the study's follow-up period, which will also evaluate the long-term outcomes for those in whom the diagnosis of disease has been delayed to see if they will be diagnosed with T1D or are protected".

The study participants, identified through the TrialNet Pathway to Prevention Study, all had a relative with type 1 diabetes.

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". Teplizumab targets T cells to lessen the destruction of beta cells.

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. Insulin is needed to convert glucose into energy. In light of the daily burden of disease management, any time without clinical diabetes has significance.

Participants chosen for the study each had a lifetime risk of clinical diagnosis nearing 100%.

The study included 76 people, both children and adults, who had several risk factors for Type 1 diabetes: They had a relative with the disease, had at least two varieties of destructive autoantibodies in their blood, and had an abnormal metabolic response to a test that measures the body's ability to process large amounts of sugar. But when the glucose enters your bloodstream, there's no insulin to allow it into your body's cells. They were also required to have had evidence of dysglycemia via an oral glucose-tolerance test.

The US biotech firm was established just three years ago, and acquired rights to teplizumab from MacroGenics, which suspended its development of the drug in 2010 after a clinical trial run with Lilly showed it failed to show sufficient efficacy in T1D patients. One group was assigned to take the experimental drug teplizumab over the course of 14 days.

All participants regularly received glucose tolerance tests until the study was completed, or until they developed clinical Type 1 diabetes - whichever came first. If teplizumab were to delay development of type 1 diabetes for a year or so, said Herold, people might think that's worth it.

On average, patients in the control group received a diabetes diagnosis within 24 months. But we also want to prevent this condition ever developing in those at risk.

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. "The rate of development of diabetes was reduced by half".

Other reports by Click Lancashire

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