Viatris Presents Late Breaking Abstract on Cenerimod at the 26th Asia-Pacific League of Associations for Rheumatology Annual Congress

Study Results - Cenerimod demonstrated safety and tolerability in Japanese patients with moderate to severe systemic lupus erythematosus (SLE), with both 2 mg and 4 mg doses showing clinically meaningful improvements in disease activity as measured by mSLEDAI-2K [1][2][3] - The 4 mg dose of cenerimod showed a higher improvement in disease activity compared to the 2 mg dose, with effects persisting long after treatment discontinuation [3] - The results are consistent with global Phase 2 CARE study findings, reinforcing the potential of cenerimod as a treatment for SLE [3][9] Study Design - The ACT-333441 study was a randomized, double-blind, parallel-group, multicenter Phase 2 trial conducted in Japan, involving 17 patients with moderate to severe SLE [2] - Patients were randomized equally to receive either 2 mg or 4 mg of cenerimod once daily, with primary endpoints focusing on safety and tolerability, and secondary endpoints measuring changes in lymphocyte count and efficacy using mSLEDAI-2K [2] About SLE and Cenerimod - Systemic lupus erythematosus (SLE) is an autoimmune disease characterized by overactive T and B lymphocytes, leading to inflammation and organ damage [5] - Cenerimod is an investigational oral S1P1 receptor modulator, offering a novel approach to treating SLE, a disease with limited treatment options [6] Regulatory and Development Status - Cenerimod has received Fast-Track designation from the U.S. FDA, aimed at accelerating development for serious conditions with unmet medical needs [8] - The OPUS program, initiated in December 2022, includes two Phase 3 studies to evaluate cenerimod's efficacy, safety, and tolerability in adult patients with moderate-to-severe SLE [7] Company Overview - Viatris Inc is a global healthcare company focused on providing access to high-quality medicines, supplying approximately 1 billion patients annually [10] - The company combines generics and brands to address global healthcare needs, with a mission to empower people to live healthier lives [10]