Provention Bio has dosed the first patients in its PREVAIL (PRV-3279 EVAluation In Lupus) study, a Phase 1b/2a clinical trial evaluating PRV-3279. PRV-3279 is a humanized diabody (a bispecific scaffold biologic molecule) targeting the B-cell surface proteins, CD32B and CD79B, which has the potential to intercept the pathophysiology of systemic lupus erythematosus (SLE) and other B cell-mediated autoimmune diseases.

The PREVAIL study consists of two parts: a Phase 1b trial in healthy volunteers, followed by a Phase 2a trial in SLE patients. The randomized, double-blind, placebo-controlled, multiple ascending dose Phase 1a study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of PRV-3279 in 16 healthy volunteers. Upon successful completion of the Phase 1a study, Provention plans to initiate the Phase 2a portion of the study in lupus patients.

"PRV-3279 offers an elegant mechanism of action designed to intercept and ameliorate the overactive B cell-driven pathology of lupus and other autoimmune diseases," said Francisco Leon, M.D., Ph.D., Co-founder and Chief Scientific Officer of Provention Bio. "We believe that PRV-3279 is uniquely differentiated to allow for rapid inhibition of activated B cells, while sparing non-activated B cells from depletion or inactivation, thereby offering the potential for a more effective yet safer alternative to current B-cell targeted therapies. We look forward to reporting data from Part 1 of the study in the first half of 2020."

Results from a prior single ascending dose Phase 1 study established proof of mechanism and showed that PRV-3279 was well-tolerated. In addition, a single dose of PRV-3279 demonstrated an inhibitory effect on the immunogenicity of hepatitis A vaccine provided to volunteers during the trial.

PRV-3279 is a humanized diabody (a bispecific scaffold biologic molecule) targeting the B-cell surface proteins, CD32B and CD79B. Simultaneous engagement of the CD32B and CD79B receptors triggers inhibition of B cell function and suppression of autoantibody production, thereby regulating B cells without causing depletion. Provention is initially developing PRV-3279 for the interception of systemic lupus erythematosus (SLE), a chronic autoimmune disorder characterized by an abnormal overactivation of B cells and subsequent pathologic production of auto-antibodies. PRV-3279 also has the potential to prevent or reduce the immunogenicity of biotherapeutics, including but not limited to gene therapy vectors and transgenes.

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