The U.S. Food and Drug Administration (FDA) has given Gracell Biotechnologies the green light to start a Phase 1/2 clinical trial to test its experimental cell therapy GC012F in people with difficult-to-treat systemic lupus erythematosus (SLE). The study’s Phase 1 portion should start in 2024 to assess the safety,…
Brepocitinib, an investigational oral therapy, failed to show any benefits beyond a placebo in a Phase 2 clinical trial that tested it in adults with moderate to severely active systemic lupus erythematosus (SLE). As such, the trial failed to meet its primary objective, as assessed using the SLE Responder…
Adding Gazyva (obinutuzumab) to standard-of-care therapy for two years reduced the risk of treatment failure, diminished kidney function or death by 60% in people with lupus nephritis, a lupus complication marked by kidney inflammation and damage. The number of lupus nephritis flares, or periods of sudden worsening, also…
Certain self-reactive antibodies, called antiphospholipid antibodies (aPLs), significantly increase the risk of a heart attack, stroke, or other cardiovascular event in people with systemic lupus erythematosus (SLE), a study shows. Among aPLS, “we identified that [anticardiolipin antibodies] and lupus anticoagulant positivity are independently associated with [cardiovascular disease], after adjusting…
Otsuka Pharmaceutical is seeking approval in Japan to manufacture and market Lupkynis (voclosporin) for the treatment of lupus nephritis, a kidney complication of systemic lupus erythematosus (SLE). The new drug application filed by Otsuka will be reviewed and decided upon by the Japanese Ministry of Health, Labour,…
A CAR T-cell therapy targeting B-cells, a type of immune cells, was found to clear disease-causing autoantibodies from the bloodstream of eight people with systemic lupus erythematosus (SLE) — without compromising the patients’ ability to respond to vaccines — new trial data show. The experimental therapy also drove the…
Kyverna Therapeutics has signed a research funding deal with Charité – Universitätsmedizin Berlin, in Germany, to study how therapies targeting immune B-cells may improve clinical outcomes of people with whole-body, or systemic, autoimmune diseases such as lupus. The deal also covers studies on CAR T-cell therapies, including Kyverna’s experimental…
Depression and anxiety are more likely in people with systemic lupus erythematosus (SLE) who also are at a greater risk of heart disease, like those with obesity or high blood pressure, a study reports. “The findings of this study suggest the need for more intensive and global care, particularly…
This year’s winners of the Lupus Foundation of America‘s Gary S. Gilkeson Career Development Award — designed to support early career scientists working on lupus research — will focus their work on areas key to patients with the autoimmune disease: pregnancy and personalized medicine. Both winners are from…
A team of scientists in Austria discovered a small molecule — now called feeblin in a nod to a Nobel laureate— that prevents the activation of immune signaling pathways implicated in systemic lupus erythematosus (SLE). This molecule was found to block the interaction of two key proteins, known as…