Provention Bio (NASDAQ:PRVB) received breakthrough therapy designation for PRV-031 for the prevention or delay of Type 1 diabetes (T1D) in at-risk individuals.
PRV-031, an anti-CD3 monoclonal antibody also known as teplizumab, is designed to slow the loss and preserve the function of insulin-producing pancreatic beta cells.
In March 2019, PRV-031 began enrolling recent onset T1D patients in a Phase 3 trial of PRV-031. The study is expected to enroll some 300 patients, aged eight to 17, who have been diagnosed with T1D in the previous six weeks.
“The ground breaking data from the at-risk trial showed, for the first time, the potential to delay the onset of T1D in individuals who are almost certain to develop clinical disease,” Ashleigh Palmer, Provention’s CEO, said in a statement.
“With this designation in place, we plan to leverage that landmark data, as well as the robust safety database from prior teplizumab studies, to support a registration filing,” she added.
