Provention Bio, Inc. (Nasdaq: PRVB), a clinical stage biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced that it 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,” stated 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. – PR Newswire