Micrograph of histomorphologic changes in a lymph node due to systemic lupus erythematosus. Credit: Nephron.

Lupus Research Alliance and its affiliate Lupus Therapeutics have partnered with Takeda Pharmaceutical to conduct a Phase I clinical trial of TAK-079 for the treatment of lupus.

Lupus is a chronic autoimmune disorder that stimulates the immune system to produce antibodies that could attack body parts instead of protecting them from infection.

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During preclinical testing, the investigational biologic demonstrated an ability to bind to and inhibit the CD38 protein present in most of the immune cells associated with creating autoantibodies.

A study involving health volunteers showed that fully human monoclonal antibody TAK-079 was found to be generally well-tolerated and led to a decrease in the number of CD38-expressing immune cells.

“We are very excited about this first clinical study looking at the potential for TAK-079 to provide a much-needed treatment option for people with lupus.”

The new randomised Phase I trial will assess the safety, pharmacokinetics and pharmacodynamics of TAK-079 in approximately 24 moderate to severe systemic lupus erythematosus (SLE) patients who did not experience adequate response to standard treatment.

Patients will be randomised to receive four subcutaneous doses of TAK-079 or placebo, along with their ongoing standard lupus therapy. The trial will take place at 20 research centres across the US.

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Lupus Therapeutics executive director Albert Roy said: “We are very excited about this first clinical study looking at the potential for TAK-079 to provide a much-needed treatment option for people with lupus.”

The trial’s primary outcome measures are the number of subjects with at least one treatment-emergent adverse event (TEAE) and serious adverse event (SAE), and those with grade III or higher TEAEs.

It will also will monitor the proportion of patients with greater than or equal to one adverse event (AE) that leads to treatment discontinuation.