New York, NY– March 1. 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.
“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,” commented Albert Roy, Executive Director of Lupus Therapeutics. “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.”
Lupus is a chronic, complex autoimmune disease that affects millions of people worldwide. More than 90% of people with lupus are women; lupus most often strikes during the childbearing years of 15-45. African Americans, Latin Americans, Asians and Native Americans are two to three times at greater risk than Caucasians. In lupus, the immune system, which is designed to protect against infection, creates antibodies that can attack any part of the body including the kidneys, brain, heart, lungs, blood, skin, and joints.
About the Lupus Research Alliance
The Lupus Research Alliance aims to transform treatment while advancing toward a cure by funding the most innovative lupus research in the world. The organization’s stringent peer review grant process fosters diverse scientific talent who are driving discovery toward better diagnostics, improved treatments and ultimately a cure for lupus. Because the Lupus Research Alliance’s Board of Directors fund all administrative and fundraising costs, 100% of all donations goes to support lupus research programs.
About Lupus Therapeutics
Lupus Therapeutics, an affiliate of the Lupus Research Alliance, aims to accelerate drug discovery and diagnostic innovation for all patients living with lupus. Lupus Therapeutics engages with biotechnology and pharmaceutical industry, as well as other investigators, to bring clinical trials to real people living with lupus. The organization aims to place the patient voice at the center of strategic planning with the most creative clinicians and scientists in the world.