PRVB up 11% on Teplizumab data for T1D. Up another 3% in after hours. Presenting at ADA tomorrow.
Provention Bio up 11% on positive teplizumab data
Jun. 15, 2020 1:35 PM ET|About: Provention Bio, Inc. (PRVB)|By: Douglas W. House, SA News Editor
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.
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