Lupus Therapeutics, Takeda Launch Phase 1 Trial of TAK-079 for Moderate to Severe SLE

The Lupus Research Alliance and its affiliate, Lupus Therapeutics, have partnered with Takeda Pharmaceutical to conduct a Phase 1 clinical trial testing Takeda’s investigational antibody TAK-079 for the treatment of systemic lupus erythematosus (SLE) patients.

The trial (NCT03724916), which will include approximately 24 participants across the U.S., is for patients with moderate to severe disease whose response to standard treatment is suboptimal.

“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,” Albert Roy, executive director of Lupus Therapeutics, said in a press release.

Because B-cells play a primary role in lupus progression, Rituxan (rituximab), an antibody that targets the CD20 protein at the surface of B-cells, has been widely used to treat this condition.

However, the subset of B-cells responsible for producing antibodies — including self-targeting antibodies — produce low levels of CD20 and are not effectively targeted by Rituxan.

TAK-079 is a fully human monoclonal antibody designed to bind with high affinity to its target protein, CD38, which is found at high levels on immune cells involved in the production of autoantibodies.

Preclinical and clinical studies in healthy volunteers have shown that the treatment effectively reduces the amount of antibody-secreting cells and is generally well-tolerated by patients.

The new Phase 1 trial is recruiting participants at 20 sites in the U.S., many of which are members of the Lupus Therapeutics’ Lupus Clinical Investigators Network (LuCIN).

Participants will be divided into three groups, each receiving a different dose of TAK-079. In each group, six patients will be randomly given the investigational therapy, while two patients will receive a placebo.

TAK-079 will be delivered under the skin once every three weeks for up to 12 weeks. All patients will also receive standard treatment for SLE.

Assessing TAK-079’s safety is the main objective of the study. Secondary outcomes include the therapy’s pharmacokinetics (how the compound behaves in the body, including its absorption, metabolism, and excretion), and pharmacodynamics (effects and action of substances within the body).

“The LuCIN sites are ready to enroll patients in the study. We encourage people with lupus to talk with their physician about whether this opportunity to take part in clinical research is right for them,” Roy said.