The U.S. Food and Drug Administration (FDA) has cleared Century Therapeutics to start a Phase 1 clinical trial that will test its off-the-shelf cell therapy CNTY-101 in people with systemic lupus erythematosus (SLE). The Phase 1 study will enroll people with moderate to severe SLE who’ve failed to respond…
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,…
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…
The U.S. Food and Drug Administration (FDA) has granted fast track designation to IMPT-514, a CAR T-cell therapy being developed by Immpact Bio for people with active, treatment-resistant lupus nephritis and systemic lupus erythematosus (SLE). Lupus nephritis is a serious complication of lupus characterized by kidney inflammation.
In both the U.S. and Europe, clinicians want to limit treatment with glucocorticoids — steroid hormones whose long-term use for autoimmune diseases is tied to serious side effects — among people with moderate to severe lupus. To that end, healthcare professionals are increasingly prescribing biological therapies like Benlysta…
Galapagos officially has launched a Phase 2 clinical trial that will test its oral therapy GLPG3667 — designed to ease disease severity in people with systemic lupus erythematosus (SLE) — at a half dozen sites in the U.S. The first participant has been randomized, or assigned to a treatment…
Immpact Bio has been cleared in the U.S. to start testing its cell therapy IMPT-514 in people with active systemic lupus erythematosus (SLE) that is refractory, or resistant to treatment. The clearance by the U.S. Food and Drug Administration “marks a pivotal milestone for our autoimmune disease clinical…
Former NFL Super Bowl champ Willie Colon hosted a golf event earlier this week to raise funds for the Lupus Research Alliance (LRA) to aid in the fight against lupus. The event is expected to raise about $400,000 and the funds will support the Jean Davis Research Grant,…
Blooms in the growth of a specific species of gut bacteria, called Ruminococcus blautia gnavus or RG, may trigger disease flares in people with lupus, a new study suggests. “Our findings provide the strongest evidence to date that silent growths of Ruminococcus blautia gnavus are tied to active serious…
Three new Phase 3 clinical trials testing the experimental therapy ianalumab in people with systemic lupus erythematosus (SLE) and lupus nephritis are now recruiting patients. All three trials are being sponsored by Novartis, the company developing ianalumab. Lupus Therapeutics, the clinical research affiliate of the Lupus Research Alliance,…