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# Provention Bio Positive Study in Type 1 Diabetes
- URL: https://www.fdaweb.com/provention-bio-positive-study-in-type-1-diabetes/
- Published: 2019-06-10T12:00:00.000Z
- Updated: 2026-09-15T01:31:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144300

Provention Bio says that a recent study showed that a single 14-day course of PRV-031 (teplizumab) significantly delayed the onset and diagnosis of clinical Type 1 diabetes compared to placebo by a median of two years in children and adults considered to be at high risk. “During the trial, 72% in the placebo group developed clinical diabetes compared to only 43% of the PRV-031 (teplizumab) group,” the [company says](http://investors.proventionbio.com/2019-06-09-A-Single-Course-of-Proventions-PRV-031-Teplizumab-Delays-Type-1-Diabetes-Onset-in-High-Risk-Individuals-by-at-Least-Two-Years?ref=fdaweb.com).  

“Based on these results, we are evaluating a regulatory path forward for PRV-031 in at-risk individuals,” the company says. “We are also assessing PRV-031 in newly-diagnosed \[Type 1 diabetes\] T1D patients in our Phase 3 PROTECT study, which commenced in April.”

Teplizumab is an anti-CD3 monoclonal antibody. In previous studies of newly diagnosed patients, PRV-031 has consistently demonstrated the capability of preserving beta cell function and reducing the need for exogenous insulin usage, the company says.