Provention Bio (NASDAQ:PRVB) has dosed the first patient in its Phase 3 clinical trial of teplizumab for Type 1 diabetes (T1D).
The trial will determine whether teplizumab, an anti-CD3 monoclonal antibody, slows the loss and preserves the function of insulin-producing pancreatic beta cells. The study is expected to enroll some 300 patients, aged eight to 17, who have been diagnosed with T1D in the previous six weeks.
“PRV-031 (teplizumab) has the potential to be the first ever disease modifying therapy in T1D, and the first drug class approved for T1D since the introduction of insulin,” Dr. Kevan Herold, professor of immunobiology and medicine at Yale University, said in a statement.
Provention expects to complete trial enrollment by the end of 2020 and intends to file a biologics license application, should the trial be successful.
