Provention Bio Positive Study in Type 1 Diabetes

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.

“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.