Viatris Reports Positive Findings from Phase 2b CARE Study on Cenerimod for SLE Treatment

Viatris Shares Results of Phase 2b CARE Study for Cenerimod

In a significant advancement for the treatment of systemic lupus erythematosus (SLE), Viatris Inc. announced the publication of its Phase 2b CARE study results assessing the efficacy and safety of cenerimod. This pivotal study, detailed in the esteemed Lancet Rheumatology, indicates that cenerimod, particularly at a 4 mg dosage, led to substantial improvements in multiple indicators of SLE disease activity over a six-month period compared to placebo while maintaining stable background SLE therapy.

The multi-center, randomized, and double-blind trial included 427 participants aged between 18 to 75 years with moderate to severe SLE. Remarkably, the study found that participants receiving cenerimod achieved a least squares mean change in the mSLEDAI-2K score of -4.04, which reflects a clinically meaningful reduction in disease activity. The difference from placebo reached statistical significance with a p-value of 0.029.

Furthermore, subgroup analyses revealed that patients exhibiting a high interferon (IFN-1) gene expression signature treated with the 4 mg dose experienced greater reductions in disease activity scores. Specifically, these patients showed an average change of -2.78 from baseline in their mSLEDAI-2K scores, alongside notable improvement rates in the SLE Responder Index (SRI-4) compared to those on placebo.

In terms of safety, cenerimod was well tolerated across all evaluated doses, with most adverse events reported as mild to moderate in severity. Importantly, there were no serious adverse events directly linked to cenerimod, further establishing its safety profile. Such findings are critical as they suggest that cenerimod's immunomodulatory action could provide a novel therapeutic avenue for those suffering from the complexities of SLE, a disease known for its unpredictable flare-ups and chronic health implications.

To enhance our understanding of cenerimod's action, related biomarker data from the CARE study were also presented in the Annals of the Rheumatic Diseases. The insights gathered regarding cenerimod’s ability to modulate immune responses specific to SLE pathology were found to align well with the observed clinical benefits of the treatment.

Viatris's Chief Research and Development Officer, Philippe Martin, emphasized the importance of these findings, stating, "We are pleased our Phase 2b CARE study results were published in two prominent journals, which underscores the urgent need for novel agents for the treatment of SLE, like cenerimod." This optimism signals the company's commitment to paving the way for addressing significant medical needs in the realm of autoimmune disorders.

Looking ahead, the promising results from the CARE study lay the groundwork for the ongoing Phase 3 OPUS program, comprising a series of clinical trials aimed at further evaluating cenerimod’s effectiveness and safety in larger patient populations with SLE.

Conclusion

The findings from the CARE study are a noteworthy step forward in the chronic management of systemic lupus erythematosus. By potentially bridging the gap between generics and specialty medications, Viatris's cenerimod could offer a new hope for patients who often face limited options in their treatment journeys. The company continues to address the critical health needs of patients globally by leveraging such innovative clinical research. As we await further developments from ongoing trials, the healthcare community remains focused on understanding and combating the implications of SLE through new therapeutic innovations.