“Biomarker data from CARE study characterizing cenerimod’s mechanism of action in systemic lupus erythematosus also published in the Annals of the Rheumatic Diseases”
🔹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 result published in Lancet rheumatology 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 Diseases 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).
CARE Study Results:
🔹At month 6, the maximum response was observed within the 4 mg group with least squares mean change from baseline in mSLEDAI-2K score being -4.04 (95% CI -4.79 to -3.28; difference vs placebo -1.19 [-2.25 to -0.12]; p=0.029).
🔹Furthermore, in a subgroup analysis, patients with a high IFN-1 gene expression signature treated with cenerimod 4 mg showed greater reduction in mSLEDAI-2K at month 6 at -2.78 as compared to placebo. Also, 24% higher SRI-4 response rate was seen as compared to placebo in this subgroup.
🔹Cenerimod 4 mg significantly reduced IFN-γ-associated proteins in addition to IFN-1 protein and gene expression signature biomarkers after 6 months of treatment when compared to placebo, with an overall larger effect size in the IFN-1 high patients. This data supports the stronger clinical response observed in the IFN-1 high population in the CARE study.
🔹Over 12 months of treatment and the follow-up period, most adverse events (AEs) were mild to moderate and there were no serious adverse events (SAEs) related to cenerimod. Cenerimod was considered to be generally well tolerated at all doses evaluated.
The abstract of the publication within Lancet Rheumatology titled, Cenerimod, a sphingosine-1-phosphate receptor modulator, versus placebo in patients with moderate-to-severe systemic lupus erythematosus (CARE): an international, double-blind, randomised, placebo-controlled, Phase 2 Trial
The full manuscript of the publication within Annals of the Rheumatic Diseases titled, Pharmacodynamics of the S1P1 receptor modulator cenerimod in a phase 2b randomised clinical trial in patients with moderate to severe SLE