Provention Bio (NASDAQ:PRVB) reports that it has filed the clinical module of its rolling U.S. marketing application for teplizumab (PRV-031) for the delay or prevention of type 1 diabetes (T1D) in at-risk people.
It initiated the process in April with the submission of the nonclinical module. It expects to file the chemistry, manufacturing and controls (CMC) module in Q4.
A Phase 3 study, PROTECT, launched in April. Its objective is to assess teplizumab's effect on slowing the loss/preserving the function of beta cells in children and adolescents recently diagnosed (in the previous eight weeks) with T1D.
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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