PRV-3279 is under clinical development by Provention Bio and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect PRV-3279’s likelihood of approval (LoA) and phase transition for Systemic Lupus Erythematosus took place on 17 May 2021, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their PRV-3279 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

PRV-3279 overview

PRV-3279 (MGD-010) is under development for the treatment of autoimmune diseases such as systemic lupus erythematosus, prevention of immunogenicity and Pompe disease. The therapeutic candidate is administered intravenously as an infusion.  It is a bi-specific bivalent antibody based on Dual-Affinity Re-Targeting (DART) technology platform. This DART scaffold is used to couple an Fv specific for the inhibitory receptor, CD32B, with an Fv specific for the Ig-beta component (CD79B) of the B-cell antigen receptor (BCR). The therapeutic candidate specifically targets B-lymphocytes to treat autoimmune diseases.

Provention Bio overview

Provention Bio (Provention), is a clinical-stage biopharmaceutical company. It develops novel therapeutics for intercepting and preventing immune-mediated diseases. The company’s pipeline product portfolio includes PRV-031 teplizumab for the treatment of type one diabetes (T1D); PRV-015 is an anti-IL-15 monoclonal antibody for gluten-free diet non-responsive celiac disease (NRCD). It also develops PRV-3279 for preventing immunogenicity and SLE; PRV-101 is a polyvalent coxsackievirus B (CVB) vaccine developed for treating type one diabetes (T1D). Provention has licensing and co-development agreement with pharmaceutical and biotherapeutic industries includes Vactech Oy, Amgen Inc and MacroGenics Inc. Provention is headqutered in Red Bank, New Jersey, the US.

Quick View PRV-3279 LOA Data

Report Segments
  • Innovator
Drug Name
  • PRV-3279
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Immunology
  • Metabolic Disorders
Key Developers
Highest Development Stage
  • Phase II

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.