Provention Bio Initiates Phase 1b/2a PREVAIL Clinical Trial Evaluating PRV-3279 in Lupus

-Bispecific Diabody Designed to Intercept B-Cell Mediated Autoimmune Diseases-

OLDWICK, NJ, USA I Aug. 8, 2019 I 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. 

About PRV-3279

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. Provention is currently evaluating PRV-3279 in the PREVAIL (PRV-3279 EVAluation In Lupus) study; additional information on the clinical trial is available at (Number NCT03955666).

About Provention Bio, Inc.

Provention Bio, Inc. (Nasdaq: PRVB) is a clinical-stage biopharmaceutical company leveraging a transformational drug development strategy that is focused on the prevention or interception of immune-mediated disease.  Provention's mission is to in-license, transform and develop therapeutic candidates targeting the high morbidity, mortality and escalating costs of autoimmune and inflammatory diseases including: type 1 diabetes (T1D), Crohn's disease, celiac disease, and lupus. Provention's diversified portfolio includes advanced-stage product development candidates that have undergone clinical testing by other companies.

SOURCE: Provention Bio

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