NEW YORK, NY. August 29 — The Lupus Research Alliance is excited to share the good news that a potential new medicine for lupus, anifrolumab, reduced disease activity versus placebo in a second Phase III study. Anifrolumab is a therapeutic antibody that blocks type I interferons, a molecule that promotes lupus inflammation. Over 15 studies funded by the Lupus Research Alliance over the past decade into the role of type I interferons were pivotal to the eventual development of anifrolumab.
Called TULIP 2, the one-year pivotal trial measured disease activity using a well-established evaluation tool called the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA). To meet the primary endpoint defined as a statistically significant and meaningful reduction in disease activity, BICLA requires improvement in organs affected by lupus with no new flares.
A Phase III trial presents the data the U.S. Food and Drug Administration uses to decide whether or not to approve a new medicine.
As noted in the press release issued today by study sponsor AstraZeneca, “TULIP 2 was the second Phase III trial designed to assess the safety and efficacy of anifrolumab as a treatment for adults with moderate-to-severe SLE. The positive BICLA response in TULIP 2 was consistent with a pre-specified analysis of the previous Phase III TULIP 1 trial, which did not meet its primary endpoint SLE Responder Index 4 (SRI4).” This is a different composite endpoint than BICLA.
TULIP 2 tested anifrolumab at a dose of 300 mg while the TULIP 1 tested anifrolumab at both 150 and 300 mg doses.
“It is tremendously gratifying to learn of this important success,” commented Dr. Mary Crow, Co-chair of the Lupus Research Alliance Scientific Advisory Board (SAB) and Physician-in-Chief/Chair of Department of Medicine at Hospital for Special Surgery and Chief of Rheumatology at HSS and NewYork-Presbyterian/Weill Cornell Medical Center. “The Lupus Research Alliance has made significant investments in research focused on the role of type I interferons in lupus, and I am personally very excited given my own research in this area.”
Lupus Research Alliance SAB Co-chair and Professor of Medicine at Weill Cornell Medicine Dr. Gary Koretzky noted, “The study is very encouraging and is a great example of how fundamental biologic discoveries inform clinical problems, taking many years of painstaking work to fruition.”
Lupus Research Alliance President and CEO Kenneth M. Farber commented, “These positive results from a pivotal Phase III trial are very hopeful for people with lupus who have waited years for desperately needed new treatment options. We look forward to seeing the full results of the study and further progress in evaluating anifrolumab as a potential therapy.”
The principal investigator of the study, Professor Eric F. Morand, Monash University, Australia is a past winner of the Lupus Research Alliance Distinguished Innovator Award which provides outstanding scientists with substantial support to conduct novel research into the fundamental causes of systemic lupus erythematosus.
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.
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.