Late-Breaking oral presentation shows that cenerimod for the treatment of moderate to severe systemic lupus erythematosus (SLE) in Japanese patients can be considered safe and well-tolerated Data shows a clinically meaningful improvement in disease activity consistent with results from other global Phase 2 studies of cenerimod PITTSBURGH , Aug. 23, 2024 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS ), a global healthcare company, presented today the results of one of its Phase 2 studies* of cenerimod (ACT-333441).
The ACT-333441 study was accepted as a late-breaking abstract and was presented during an oral presentation at the 26 th Asia-Pacific League of Associations for Rheumatology (APLAR) Annual Congress. The congress is being held August 21-25, 2024 , in Suntec, Singapore . The ACT-333441 study was a randomized, double-blind, parallel-group, multicenter, Phase 2 study that was conducted in Japan and evaluated the safety, pharmacodynamics (PD), and efficacy of cenerimod, a selective S1P 1 receptor modulator, in 17 Japanese patients with moderate to severe systemic lupus erythematosus (SLE).
Adult patients receiving SLE background treatment were randomized equally to either 2 mg or 4 mg cenerimod (once-daily, oral dosing). The primary endpoint of the study measured safety and tolerability, and the secondary endpoint measured a change in total lymphocyte count and the efficacy was assessed using a modified SLEDAI-2K (mSLEDAI-2K) score. Both cenerimod doses were considered safe.