Micrograph showing vacuolar interface dermatitis, as may be seen in SLE. Credit: Nephron.

Provention Bio has dosed the first patients in its Phase Ib/IIa PREVAIL clinical trial of humanised diabody PRV-3279.

PRV-3279 targets the B-cell surface proteins, CD32B and CD79B.

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The PREVAIL study comprises a Phase Ib trial in healthy volunteers, followed by a Phase IIa trial in patients with systemic lupus erythematosus (SLE).

During the randomised, double-blind, placebo-controlled, multiple-ascending dose Phase Ia study, the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of PRV-3279 will be evaluated in 16 healthy volunteers.

After completion, the Phase IIa portion of the study will be initiated in Lupus patients.

Provention Bio co-founder and chief scientific officer Francisco Leon said: “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.

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“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.”

Data from the first part of the study is expected in the first half of next year.

Results from a prior single-ascending dose Phase I study showed that PRV-3279 was well-tolerated.

A single dose of the humanised diabody also demonstrated an inhibitory effect on the immunogenicity of hepatitis A vaccine provided to volunteers at the time of the trial.

Provention is initially developing PRV-3279 for the interception of SLE, a chronic autoimmune disorder characterised by an abnormal overactivation of B cells and subsequent pathologic production of auto-antibodies.

In April, Provention Bio concluded patient enrolment in the Phase IIa PRINCE clinical trial of PRV-6527 for the treatment of patients with moderate-to-severe Crohn’s disease.