Lupus Therapeutics Partners with Takeda on Phase 1 Trial

The Lupus Research Alliance and its affiliate, Lupus Therapeutics announced a collaboration with Takeda Pharmaceutical Company Limited, to evaluate the investigational biologic TAK-079 as a potential new therapy for lupus in a Phase 1 trial (NCT03724916). The national study will be conducted in 20 research centers throughout the country, many of which are members of Lupus Therapeutics` Lupus Clinical Investigators Network (LuCIN).

TAK-079 is a fully human monoclonal antibody, meaning that it is produced in the laboratory using human DNA sequences. In preclinical studies, TAK-079 attached to and inhibited CD38, a protein found on many immune cells that are involved in producing autoantibodies. Data from a study with healthy volunteers suggested that TAK-079 is generally well-tolerated and showed a decrease in the number of immune cells that expressed CD38.

The Phase 1 study will enroll patients with moderate to severe lupus and aims to evaluate the safety of TAK-079 as well as its pharmacokinetics (how it is absorbed, distributed, metabolized and excreted from the body) and its pharmacodynamics (how it works and affects the body). To join the trial, patients must have moderate to severe disease activity that has not responded well enough to standard lupus treatment. Participants will receive up to four doses of either TAK-079 or placebo, in combination with their ongoing standard lupus treatment.

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