The European Medicines Agency (EMA) has granted XTMAB-16, Xentria‘s investigational antibody therapy, orphan drug designation for sarcoidosis. The status is intended to help speed the development of therapies that would fulfill an unmet health need for people with life-threatening or chronically debilitating rare diseases, which are defined as…
EFZO-FIT, a Phase 3 trial that’s testing treatment candidate efzofitimod in people with pulmonary sarcoidosis, is continuing  following a pre-planned interim safety review, with enrollment expected to finish in the first half of 2024. A data safety and monitoring board (DSMB) examined the trial’s available safety and tolerability…
Workplace exposure to silica, mold/mildew, and pesticides were associated with an increased risk of pulmonary sarcoidosis in a recent review study. By analyzing data from dozens of published studies, scientists identified more than 80 different airborne factors that have been linked to the disease in at least one study.
Treatment with tumor necrosis factor-alpha (TNF-a) inhibitors — which block a type of immune protein in the body — was found to ease signs of inflammation and reduce the need for corticosteroids in people with cardiac sarcoidosis in a new analysis. Safety data, meanwhile, indicated that such treatments were…
Top-line data from an ongoing Phase 2 trial testing Kinevant Sciences’ experimental therapy namilumab in adults with pulmonary sarcoidosis are expected in the second half of 2024. That’s according to a business update from Roivant Sciences, the parent company to Kinevant. Called RESOLVE-Lung (NCT05314517), the…
The U.S. Food and Drug Administration (FDA) has greenlit a month-old request by Molecure to begin a Phase 2 clinical trial of its investigational oral therapy OATD-01 in people with pulmonary sarcoidosis. The proof-of-concept study, which is ready to launch, according to Molecure, will be the first…
Molecure is seeking permission from the U.S. Food and Drug Administration (FDA) to conduct a Phase 2 clinical trial of its oral treatment candidate OATD-01 in people with pulmonary sarcoidosis. The request came in the form of an investigational new drug application (IND) submitted to the FDA. Should…
Only about half of sarcoidosis patients showing signs of muscle disease, or myopathy, have the small clumps of immune cells in their muscles that characterize sarcoidosis, a study showed. When these clumps, called granulomas, weren’t present with muscle symptoms, myopathy was most often linked to inclusion body myositis (IBM),…
The European Commission (EC) has granted orphan drug designation to aTyr Pharma’s lead therapeutic candidate efzofitimod for treating sarcoidosis. Orphan drug status is granted to investigational therapies that show significant potential for treating chronic or life-threatening disease that affect no more than five in 10,000 people in the…
Infliximab — marketed as Remicade and biosimilars — had steroid-sparing effects superior to methotrexate in the treatment of cardiac sarcoidosis, a small study found. The success rate of a tapering course of corticosteroids was significantly better when infliximab was added to the regimen than when the steroid was used…
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