New York, NY– June 27, 2019. The Lupus Research Alliance (LRA) and its affiliate, Lupus Therapeutics, announced that it has broadened its collaboration with Bristol-Myers Squibb (BMS) to assess the investigational drug BMS-986165 as a potential new therapy for lupus nephritis (LN). This expands the existing collaboration in systemic lupus erythematosus (SLE). Lupus nephritis refers to the kidney damage that affects about half of people with lupus; more treatment options are critically needed.
BMS-986165 is an oral investigational drug that selectively inhibits the action of tyrosine kinase 2 (TYK2), an enzyme involved in many autoimmune diseases, including LN and SLE.
Together, Bristol-Myers Squibb and Lupus Therapeutics will identify sites within the Lupus Clinical Investigators Network (LuCIN) that may be included in a Phase 2 study to evaluate the efficacy and safety of BMS-986165 in patients with lupus nephritis. Similarly, LuCIN sites are part of the ongoing Phase 2 trial in SLE.
The Phase 2 randomized, blinded, placebo-controlled study is evaluating the long-term effectiveness and safety of BMS-986165 at three potential doses plus standard therapy versus placebo and standard therapy among patients with SLE. The study seeks 360 participants at approximately 200 locations throughout the world.
Lupus Nephritis Study (NCT03943147)
The Phase 2 randomized, blinded, placebo-controlled study is evaluating the efficacy and safety of BMS-986165 in people diagnosed with lupus nephritis; it is being conducted at approximately 100 research centers throughout the world, including North American LuCIN centers.
“We are very excited to work with BMS on two important studies looking at a potential therapy for lupus and lupus nephritis,” commented Albert Roy, Executive Director of Lupus Therapeutics. “If interested in an opportunity to take part in clinical research, patients should speak with their physicians about what is involved and whether either of these studies may be right for them.”
John Throup, Development Team Lead, Bristol-Myers Squibb, commented, “Lupus nephritis is one of the most debilitating manifestations of systemic lupus, with approximately 10% of patients progressing to end stage renal disease. New therapies are urgently needed and, with its network of investigators, Lupus Therapeutics is well positioned to help us assess the potential of BMS-986165 in this disease. We are delighted to expand our collaboration with Lupus Therapeutics to include both systemic lupus erythematosus and lupus nephritis.”
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, Latinx, 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. Kidney damage (lupus nephritis) is one of the more common complications of lupus, affecting as many as half of adults with lupus.[i] When the kidneys become inflamed (nephritis), they can’t effectively get rid of waste products and other toxins from the body.
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.
[i] Lupus and Kidney Disease. (Lupus Nephritis). National Institute of Diabetes and Digestive and Kidney Diseases. Available at: https://www.niddk.nih.gov/health-information/kidney-disease/lupus-nephritis. Accessed June 3, 2019.