Netherlands-based immunology company argenx has announced plans to advance to a second dose cohort in the Phase II ARDA study (NCT05225675) evaluating its antibody empasiprubart (ARGX-117) in multifocal motor neuropathy (MMN).
This comes after an independent data monitoring committee confirmed the safety and tolerability profile of ARGX-117 was consistent with results from an earlier Phase I study.
Currently, 22 patients are enrolled in the study, with nine having completed the full 16-week treatment period. argenx claimed that an early efficacy assessment demonstrated proof-of-concept for ARGX-117 in treating MMN, with data showing a distinct difference between the drug and placebo.
With this new cohort, argenx is expected to enrol 48 patients total in the study. In addition to assessing the safety and efficacy of ARGX-117, it will populate a PK/PD model to inform Phase III study dose selection.
ARDA (NCT05225675) is a randomised, double-blind, placebo-controlled, multicentre study evaluating the effects of two dose regimens of ARGX-117 in MMN-diagnosed adults. It involves an IVIg dependency and monitoring period, with two cohorts being dosed over 16 weeks.
MMN is a rare, progressive muscle disorder primarily affecting men. It is often mistaken for amyotrophic lateral sclerosis (Lou Gehrig’s disease), but is far more treatable, with an early diagnosis often resulting in quick recovery.
The only MMN therapies currently available are immune globulin, with many pipeline therapies being the same. But argenx claims that this leaves a gap in the market since patients receiving immune globulin often still experience disease progression.
ARGX-117 is a humanised sweeping antibody, a recycling antibody that binds to Fc receptors and enhances the cellular uptake of an antibody-antigen complex. It binds to C2, a complement protein, and blocks classical and lectin pathways of the complement cascade thereby reducing tissue inflammation.
According to GlobalData’s drugs database, ARGX-117 is one of four new MMN treatments currently in development – and the only one to have reached Phase II.
GlobalData is the parent company of Pharmaceutical Technology.
While ARDA is concerned with evaluating ARGX-117’s applications in treating MMN, the antibody is also under development for treating autoimmune haemolytic anaemia (AIHA), dermatomyositis and antibody-mediated rejection (AMR) following organ transplants.
In the Phase II study, safety and tolerability are the primary endpoints, with time to IVIg retreatment, biomarker analyses of C2 levels, changes in measurements on key clinical efficacy scores and patient-reported quality of life outcome measures also being studied.
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