US-based biopharmaceutical company Provention Bio has reported positive data from the Phase Ib portion of the PREVAIL (PRV-3279 EVAluation In Lupus) study of PRV-3279 in healthy volunteers.
PRV-3279 is a humanised diabody targeting B-cell surface proteins CD32B and CD79B. It is developed for the interception of systemic lupus erythematosus (SLE), a chronic autoimmune disorder also known as lupus.
The double-blind, placebo-controlled, multiple ascending dose Phase Ib portion of the PREVAIL study found that PRV-3279 was well-tolerated in the subjects.
Pharmacokinetic parameters were stated generally dose-proportional. The high levels of B-cell engagement resulted in durable pharmacodynamic responses in the study, which enrolled 16 healthy volunteers.
Provention Bio co-founder and chief scientific officer Francisco Leon said: “These results build on prior clinical data with PRV-3279 and existing evidence of the role of CD32B in lupus. These data further increase our enthusiasm for this potentially groundbreaking treatment of B-cell driven immunologic conditions with high unmet need, such as lupus.”
The company is planning to begin the Phase IIa portion of the PREVAIL study in the first half next year. The study, which will analyse the drug in lupus patients, will be based on the results from the current trial.
These Phase Ib results are also expected to support a second development pathway for the prevention of immunogenicity of biotherapeutics such as gene therapy products.
SLE causes inflammation, tissue injury and damage in nearly every organ.
Provention Bio dosed the first patients in its Phase Ib/IIa PREVAIL clinical trial of humanised diabody PRV-3279 in August last year.