Abiopharma

Provention Bio Inc (the company became a subdivision of the company Sanofi ADR (SNY)) (PRVB) Announces Clinical Trial Update Provention Bio Inc (the company became a subdivision of the company Sanofi ADR (SNY)) (PRVB) provided an update on its clinical development programs. Clinical Development Highlights:

• Drug Program: results, preparations
• Diseases/Conditions: support of its ongoing review
• Update Type: Trial Timeline Adjustment
• Primary Factors: Pandemic-Related Challenges, Patient Enrollment, Regulatory Process
• Collaboration: Ashleigh Palmer
  • targeting the B-cell surface proteins CD32B and CD79B. The PREVAIL-2 study is a Phase 2a proof-of-concept (POC) study in moderate-to-severe SLE patients induced into response with a short course of corticosteroids, and then monitored for relapse, after randomization to either PRV-3279
  • targeting all key CVB strains associated with type 1 diabetes autoimmunity. Provention is developing PRV-101 for the prevention of CVB-triggered autoimmune damage to pancreatic beta cells that may progress to T1D and damage to intestinal cells that may lead to celiac disease. In this final analysis, 6 months following the final administered dose of the vaccine, PRV-101 met the primary endpoint confirming the tolerability observed in the previously reported interim analysis, with no treatment-emergent serious adverse events, adverse events of special interest, or adverse events leading to study drug discontinuation or study withdrawal. The results also showed durability of viral neutralizing antibody (VNT) responses. Six months following the final dosing, the percentages of subjects in the high-dose PRV-101 arm who maintained high titers of VNT were 100% for the majority of serotypes included in the vaccine and no less than 90% for all serotypes. The Company continues to seek and evaluate partnership opportunities to further the clinical development of PRV-101. Second Quarter 2022