The Lupus Research Alliance (LRA) and its affiliate, Lupus Therapeutics, are broadening their collaboration with Bristol-Myers Squibb (BMS) to assess the investigative drug BMS-986165 as a potential new therapy for Lupus nephritis (LN).
This announcement represents an expansion of their existing collaboration in systemic Lupus erythematosus (SLE). Lupus nephritis refers to the kidney damage that affects about half of people with Lupus. It is evident that more treatment options are critically needed.
What is BMS-986165?
BMS-986165 is an oral investigative drug that selectively inhibits the action of tyrosine kinase 2 (TYK2), an enzyme involved in many autoimmune diseases, including LN and SLE.
How will BMS and Lupus Therapeutics Collaborate?
The two will identify research 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.
What is LuCIN?
The Lupus Clinical Investigators Network (LuCIN) is a North American-based Lupus clinical trials network composed of 57 of the most reputable academic research medical centers in the world. LuCIN brings together the biopharma industry and Lupus experts to evaluate the safety and effectiveness of new therapies for Lupus. The investigators and other specialized personnel within LuCIN are experts at planning and conducting Lupus clinical research on new investigative drugs or repurposed drugs, since these repurposed drugs have already been extensively tested for other diseases and found to be safe and less risky.
What are Current Studies LuCIN Participate In?
Several. Some examples include the VALUE Study (electronic/mobile-based patient reported outcomes); RIFLE Study (evaluate delayed-released Prednisone in SLE); DIVINE Study (novel imaging procedure to assess Lupus Nephritis); IBERDOMIDE Study (a Phase II study to evaluate a novel, small-molecule therapy in SLE); EVOBRUTINIB Study (a Phase II study to evaluate a novel, Bruton’s Tyrosine Kinase inhibitor (BTKi) in SLE and the ORKIDS Study (a study to evaluate the effects of krill oil in SLE).
What is the Lupus Research Alliance?
With an aim to transform Lupus treatment while advancing toward a cure, they are involved with funding most innovative Lupus research around the world. The organization prides itself on a stringent peer review grant process that fosters diverse scientific talent driven, directed and dedicated to Lupus treatments and ultimately a cure someday. The Lupus Research Alliance’s Board of Directors fund all administrative and fundraising costs, 100% of all donations go to support Lupus research programs. They have given over 500 grants totaling $200 million.
What is Lupus Therapeutics?
An affiliate to the Lupus Research Alliance, they are dedicated to establishing a novel clinical trials network composed of some of the worlds’ leading academic research centers. They mobilize this Lupus scientific community to identify, evaluate and conduct trials on the most promising new treatments by leveraging lupus Key Opinion Leader (KOL) engagement through Lupus Therapeutics Consultative Services. Moreover, they are actively engaging with patient communities to educate and support new treatment development through the coordination of Patient Advisory Boards and through Patient Advocates for Lupus Studies (PALS) program. Finally, as was evident by the BMS announcement, the group is actively forging partnerships with the biopharma industry.
Joint Bristol-Myers Squibb and Lupus Therapeutics Clinical Trial Collaboration
Together BMS 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. Additionally, LuCIN sites are part of the ongoing Phase 2 trial in SLE.
Active Studies Collaborative Studies
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 vs. placebo and standard therapy among patients with SLE. The study seeks 360 participants at approximately 200 locations worldwide.
The Phase 2 randomized, blinded, placebo-controlled study is evaluating the efficacy and safety of BMS-986165 in people diagnosed with Lupus Nephritis. The study is being conducted at approximately 100 research centers throughout the world, including North American LuCIN centers.