First Patient Dosed in Early Trial Evaluating Provention’s PRV-3279 for SLE

Provention Bio has dosed the first lupus patient enrolled in the Phase 1b/2 trial testing the safety and pharmaceutical properties of its experimental B-cell-targeted therapy PRV-3279.

Results from the first part of the PREVAIL study, done in healthy volunteers, are expected for the first half of 2020.

PRV-3279 (formerly MGD010) is a humanized antibody-based molecule designed to inhibit the function of immune B-cells. The treatment’s goal is to intercept systemic lupus erythematosus (SLE) before it becomes a chronic, life-altering condition. The agent was originally developed by MacroGenics, which licensed all the rights to Provention.

In lupus patients, abnormally overactive B-cells, the antibody-producing immune cells, release autoantibodies that mistakenly attack the body’s own cells, causing this autoimmune condition.

PRV-3279 is designed to simultaneously block two surface markers of B-cells, CD32B and CD79B. This is believed to inhibit B-cell function and suppress autoantibody production.

Results from an early dose escalation study showed that PRV-3279 was well-tolerated in healthy individuals. A single dose also was seen to inhibit the efficacy of hepatitis A vaccine.

Based on this early data, Provention launched PREVAIL (NCT03955666), a Phase 1b/2a trial testing multiple ascending doses of PRV-3270 in healthy volunteers, followed by an expansion into SLE patients.

The study will run in two parts. The first, a double-blind, placebo-controlled Phase 1a study, will evaluate PRV-3279’s safety, pharmacokinetics (agent’s distribution in the body), and pharmacodynamics (agent’s effects in the body) in 16 healthy volunteers. The treatment will be given as intravenous or into the vein infusions every two weeks. This part is expected to commence in the second half of 2019.

Upon its completion, a Phase 2a trial will follow in SLE patients. More information on the clinical trial PREVAIL is available here.

“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,” Francisco Leon, MD, PhD, Provention’s co-founder and chief scientific officer, said in a press release.

“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,” he added.

Provention also is pursuing the use of PRV-3279 for preventing or reducing immunogenicity — the ability of a particular substance to provoke an immune response in the body — of biological therapies, including gene therapy.