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A Phase 2 trial testing the effectiveness of afimetoran, Bristol-Myers Squibbs

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The Phase 2 trial (NCT04895696) is recruiting up to 344 SLE patients, ages 18–70, at study sites worldwide.

A Phase 1 trial (NCT04493541) assessing afimetoran’s safety in up to 24 adults, ages 18–65, with active cutaneous lupus erythematosus (CLE) is still ongoing. The trial is recruiting participants at a site in Germany.Two disease-specific treatments have been approved to date for lupus: AstraZeneca’s Saphnelo (anifrolumab) and GlaxoSmithKline’s Benlysta (belimumab). Both, administered via injection or infusion, act in different ways to modulate the immune system.Other treatments, such as corticosteroids, can be accompanied by significant safety concerns and are not specifically designed to treat the condition.BMS researchers sought to design a lupus-specific treatment that could be delivered orally and that would selectively block toll-like receptors (TLR) 7 and 8, two proteins thought to be involved in the autoimmune attacks that characterize lupus.After screening and identifying small molecules that could block these receptors, investigators modified them so they could be more specific to TLR 7 and 8, more potent, and would be able to be given orally.Afimetoran was the most promising small molecule candidate that emerged from that screening.In mouse models, it was able to prevent lupus symptoms in animals treated before the onset of disease and reverse organ damage when given after symptoms had already started.It also significantly improved animals’ survival relative to untreated mice or mice treated with prednisolone, a steroid.“With afimetoran, not only could we prevent the development of lupus-like symptoms in mice before their disease onset, but we could actually reverse the symptoms and prevent death in animals that were days or weeks away from succumbing to the disease,” Dyckman said. “We hadn’t seen that reversal with other mechanisms we had evaluated, so we were particularly excited about that finding.”The medication was also safe with corticosteroids and the combination led to better effects than either medication alone in both cell and mouse models of lupus. This could enable patients to use lower doses of steroids and experience fewer safety concerns, or avoid them altogether.recorded media briefing.Other measures of disease activity, corticosteroid use, and joint swelling, as well as safety, will be assessed as secondary goals.Sjögren’s syndrome, psoriasis, and rheumatoid arthritis.“Lupus is such a heterogeneous disease that it’s unlikely that any single approach will provide relief for all of the patients out there,”  he said.

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