Provention Bio has commenced a Phase IIa clinical trial of its investigational humanised bispecific DART molecule, PRV-3279, to treat patients with moderate-to-severe systemic lupus erythematosus (SLE), a chronic autoimmune disease.

The proof-of-concept (POC) PRV-3279 EVAluation In Lupus- Phase 2 (PREVAIL-2) study will examine PRV-3279’s efficacy and safety against placebo. Data from PREVAIL-2 trial is expected in the first half of 2024.

Subject screening has already commenced in the US to identify and recruit nearly 100 patients who will be given six monthly infusions of PRV-3279 or placebo, with primary efficacy readout at 24 weeks.

The double-blind, randomised, placebo-controlled study will investigate PRV-3279 versus placebo, administered every four weeks over a period of five months.

This will be followed by an efficacy and safety follow up for eight weeks.

Assessment of the ability of PRV-3279 to reduce SLE flare is the study’s primary endpoint.

For this trial, the company will recruit adult subjects with SLE across nearly 28 centres in the US and Hong Kong.

As part of a strategic collaboration, Provention Bio and Hangzhou Zhongmei Huadong Pharmaceutical will develop and market PRV-3279 in Greater China.

In a previous single ascending dose Phase I study and a multiple ascending dose Phase Ib study, PREVAIL-1, PRV-3279 was found to be well-tolerated.

It established proof of mechanism with prolonged inhibition of B cell function.

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 allows for rapid inhibition of activated B cells, while sparing non-activated B cells from depletion or inactivation, which may offer the potential for an alternative to current B cell-targeting therapies with a more favorable safety profile.”