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.

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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.

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

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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.”