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Provention Bio Jumps 300% After Pipeline Asset Shows Efficacy In Delaying Onset Of Diabetes In At-Risk Patients

Benzinga logo Benzinga 6/10/2019 Shanthi Rexaline
a group of people sitting at a table in front of a building© Provided by Accretive Capital LLC

Shares of biotech Provention Bio Inc (NASDAQ: PRVB) are trading sharply higher Monday following publication of the results of a National Institutes of Health, or NIH,-sponsored study online in the New England Journal of Medicine as well as presentation of the same at the 79th Annual American Diabetes Association Meeting.

What Happened

Provention Bio said the "At-Risk" study that evaluated its PRV-031, an anti-CD3 monoclonal antibody, for the prevention or delay of clinical Type 1 diabetes, or TID, in relatives who are at high-risk of developing the disease showed that a single 14-day course of the investigational asset significantly delayed the onset and diagnosis of clinical T1D by a median of two years in children, compared to placebo.

The median time to clinical diagnosis of T1D for the treatment arm was just over 48 months compared to 24 months for the control arm.

During the trial, 72 percent in the placebo group developed clinical diabetes compared to only 43 percent for the PRV-031 group.

PRV-031 was also well tolerated, with the safety data consistent with prior studies in newly diagnosed patients, the company said.

Why It's Important

Delaying the onset of diabetes in at-risk patients is considered a breakthrough, as a recent study showed the life expectancy of patients diagnosed with T1D before the age of 10 is reduced by as much as 16 years, on average, Provention Bio said.

Provention Bio said, based on the results, it's evaluating a regulatory path for PRV-031 at risk-patients. The asset is also currently being evaluated in a Phase 3 study, dubbed PROTECT, in newly-diagnosed T1D patients.

At publication time, Provention Bio shares were skyrocketing 328 percent to $18.63.

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