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.
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.
“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.