Viatris Inc. (NASDAQ: VTRS) announced the publication of Phase 2b CARE study results evaluating the efficacy and safety of cenerimod in adults with moderate-to-severe systemic lupus erythematosus (SLE). The results, published in Lancet Rheumatologyⁱ, showed cenerimod 4 mg demonstrated clinically meaningful and sustained improvement from baseline on multiple measures of SLE disease activity compared to placebo, in addition to stable background SLE therapy. Cenerimod was shown to be well tolerated with an adverse event profile consistent with the mechanism of action.

In addition, results from the analysis of the CARE study on SLE-related biomarker data were published in the Annals of the Rheumatic Diseasesⁱⁱ and further characterized the mechanism of action of cenerimod in patients living with SLE.

"We are pleased our Phase 2b CARE study results were published in two prominent journals, Lancet Rheumatology and Annals of the Rheumatic Diseases, which underscores the urgent need for novel agents for the treatment of SLE, like cenerimod," said Viatris Chief R&D Officer Philippe Martin. "The biomarker data highlights the multifaceted immunomodulatory properties of cenerimod targeting key aspects of SLE pathogenesis."

This data informed the design and dose selection of the ongoing Phase 3 OPUS program (OPUS-1 NCT05648500, OPUS-2 NCT05672576, OPUS-OLE NCT06475742).

The CARE study was a double-blind, randomized, placebo-controlled, Phase 2b trial in adults aged 18-75 years old with moderate-to-severe SLE. Out of the 810 patients screened, 427 were randomly assigned (1:1:1:1:1) to once-daily oral cenerimod at 0.5 mg, 1 mg, 2 mg, or 4 mg or placebo, in addition to stable background SLE therapy, and followed up for 12 months. The primary endpoint was change from baseline to month 6 in mSLEDAI-2K score of cenerimod versus placebo.