Provention Bio Starts Mid-Stage Lupus Trial; Data Expected In 2024

Provention Bio Inc PRVB has initiated the Phase 2a PREVAIL-2 study evaluating PRV-3279 in systemic lupus erythematosus (SLE).

• PRV-3279 is a humanized bispecific DART molecule targeting the B-cell surface proteins CD32B & CD79B, which can intercept the pathophysiology of SLE & other B cell-mediated autoimmune diseases and prevent the immunogenicity of gene therapies.
• SLE is a chronic autoimmune disease that can cause inflammation and pain throughout the body. 
• Also See: Provention Bio Shares Gain On Teplizumab Regulatory Update For Type 1 Diabetes.
• The study will be conducted in the US and Hong Kong. Screening has commenced in the US, intending to identify and enroll approximately 100 patients to 6 monthly infusions of PRV-3279 or placebo, with primary efficacy readout at 24 weeks. 
• The Company plans to report data from PREVAIL-2 in 1H of 2024.
• PRV-3279 was well-tolerated in a prior single ascending dose Phase 1 study and a multiple ascending dose Phase 1b PREVAIL-1 study.
• The studies showed long-lasting inhibition of B cell function as shown by reduction in IgM production eight weeks post last dose of PRV-3279.
• Price Action: PRVB shares closed at $4.29 on Thursday.