Phase 1b Trial Approved to Get Started for Systemic Lupus Erythematosus in China

I-Mab has just announced China’s Center for Drug Evaluation has officially approved the new drug application for felzartamab as therapy for systemic lupus erythematosus (SLE). That means that a Phase 1b trial for the condition can commence.

I-Mab is working on two trials for multiple myeloma along with this investigation for SLE. Further, felzartamab is being studied in anti-PLA2R antibody-positive membranous nephropathy.

SLE is a chronic autoimmune condition which causes damage to many organs. Researchers are hopeful that fellzartamab could treat the pathophysiology of the condition and allow long-term management of the disease.

Felzartamab

Felzartamab is a CD38 antibody which was created using MorphoSys’ HuCAL technology. It works by recruiting the body’s immune cells to kill the tumor in the body.

Based on its method of action, researchers are also hopeful that this therapy could work in many cancers and autoimmune conditions. Considering that CD38 is present on multiple myeloma cells, which are prominently expressed antigens on malignant plasma cells, felzartamab could support many conditions.

For SLE, since felzartama targets the cells specifically pathogenic to the condition, it could lead to better outcomes than traditional therapies. Preclinical investigations have already showed the disease-modifying effects of this therapy for SLE. 

This Phase 1b trial is called T felzartamab  and it aims to investigate the safety, pharmacokinetics, tolerability, as well as pharmacodynamics of the therapy in SLE patients.

The trial will be completed at multiple centers across China.

You can read more about this investigative therapy and upcoming clinical trial here.

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