Viatris Unveils Cenerimod Data at 26th APLAR Congress

Viatris Inc., a global healthcare company, has unveiled promising results from a Phase 2 study of cenerimod (ACT-333441) for treating moderate to severe systemic lupus erythematosus (SLE) in Japanese patients. The findings were presented at the 26th Asia-Pacific League of Associations for Rheumatology (APLAR) Annual Congress held in Suntec, Singapore from August 21-25, 2024.

The study, accepted as a late-breaking abstract, involved a randomized, double-blind, parallel-group, multicenter approach. Conducted exclusively in Japan, it evaluated the safety, pharmacodynamics, and efficacy of cenerimod, a selective S1P1 receptor modulator, in 17 adult Japanese patients with moderate to severe SLE. Participants were divided equally into two groups, receiving either 2 mg or 4 mg of cenerimod daily, alongside their existing SLE background treatment.

The primary goal was to assess the safety and tolerability of cenerimod. Secondary goals included measuring changes in total lymphocyte count and evaluating efficacy using a modified SLEDAI-2K score. Results indicated that both 2 mg and 4 mg doses of cenerimod were safe and well-tolerated. A notable decrease in lymphocyte counts was observed in both dosage groups, aligning with cenerimod's mechanism of action. Importantly, these counts were reversible upon discontinuation of treatment.

Clinical improvements in disease activity were seen in both dosage groups, with more pronounced results in the 4 mg group. These improvements, measured by the mSLEDAI-2K score, persisted even after treatment cessation. The results paralleled those of the global Phase 2 CARE study, reinforcing cenerimod's potential as a therapeutic option for SLE.

To further explore the efficacy and safety of cenerimod, Viatris has initiated the OPUS program in December 2022. This program consists of two multicenter, randomized, double-blind, placebo-controlled Phase 3 studies. The primary aim is to evaluate the effectiveness of 4 mg cenerimod in reducing disease activity in adult patients with moderate-to-severe SLE. The primary endpoint is the response on the SLE Responder Index 4 (SRI-4) at 12 months, compared to baseline. Secondary endpoints include the response on the BICLA (BILAG-Based Composite Lupus Assessment) at 12 months and measures of sustained disease control.

Systemic lupus erythematosus (SLE) is an autoimmune disease where the immune system attacks healthy tissue, causing inflammation and organ damage. The exact cause of SLE remains unknown, but T and B lymphocytes play a significant role in its development. In SLE patients, these lymphocytes become overactive and produce autoantibodies that attack various tissues.

Cenerimod, being a selective S1P1 receptor modulator, shows potential in addressing this overactivity. As an oral, once-daily tablet, it offers a novel approach for SLE treatment, a disease with limited therapeutic options. The U.S. Food and Drug Administration (FDA) has granted Fast-Track designation to cenerimod, facilitating its development and review.

The Phase 2 CARE study further supports these findings. Conducted over 18 months with 427 randomized patients, it evaluated the efficacy, safety, and tolerability of various cenerimod doses. The primary endpoint was the change from baseline to six months in the mSLEDAI-2K score. Secondary endpoints included improvements in the SLE Responder Index (SRI-4) and the BILAG-2004 scores. Safety was assessed through the monitoring of adverse events.

Viatris Inc., headquartered in Pittsburgh, is dedicated to bridging the gap between generic and branded medicines. The company supplies high-quality medications to approximately 1 billion patients globally each year. With a focus on addressing some of the world's most persistent health challenges, Viatris aims to empower people at every stage of life.

In conclusion, the promising results from the Phase 2 study of cenerimod highlight its potential as a safe and effective treatment for moderate to severe SLE. The ongoing OPUS program and the CARE study further support its development, offering hope for improved therapeutic options for SLE patients.