Provention Bio up 11% on positive teplizumab data

Provention Bio (PRVB +10.6%) is up on a 4x surge in volume in reaction to follow-up data from a Phase 2 study, “At Risk” TN-10, evaluating teplizumab for preventing/delaying the onset of type 1 diabetes (T1D) in relatives of type 1 diabetics deemed “at very high risk” of developing the condition.

Results showed that a single 14-day course of teplizumab significantly delayed the onset of T1D in presymptomatic patients by a median of three years compared to placebo.

In addition, declines in C-peptide levels (reductions indicate destruction of insulin-producing beta cells in the pancreas) in treated patients stabilized than reversed, suggesting possible restoration of insulin production by these cells.

Treatment with teplizumab resulted in 54% less risk of progressing to insulin-dependent T1D compared to placebo.

No new safety signals were observed.

The company expects to complete its U.S. marketing application in Q4.

Teplizumab is a CD3-targeted monoclonal antibody designed to slow the loss of insulin-producing beta cells in the pancreas while preserving beta cell function as measured by C-peptide.

https://seekingalpha.com/news/3583109-provention-bio-up-11-on-positive-teplizumab-data