Cenerimod

Viatris Acquires Global Rights to Cenerimod for Autoimmune Diseases with $10M Nxera Deal

3 months ago

• Viatris has secured exclusive global rights to cenerimod, a novel oral S1P1 receptor modulator, through a $10 million upfront payment to Nxera Pharma for Japan and APAC territories. • Cenerimod is currently advancing in Phase 3 trials as a potential first-in-class oral therapy for systemic lupus erythematosus, showing promise across multiple autoimmune disorders. • The agreement includes milestone payments upon Japanese regulatory approval and royalties on net sales, strengthening Viatris's position in the immunology therapeutic space.

Cenerimod Shows Promise in Treating Systemic Lupus Erythematosus: Phase 2b CARE Study Results

5 months ago

• The Phase 2b CARE study demonstrated that cenerimod, a selective S1P1 receptor modulator, led to clinically meaningful improvements in adults with moderate-to-severe SLE. • Patients treated with cenerimod 4 mg showed significant and lasting improvements in SLE disease activity compared to placebo, alongside stable background therapy. • Biomarker data from the CARE study further elucidated cenerimod's immunomodulatory effects on lymphocytes, inflammation, and antigen transport in SLE pathogenesis. • The positive results from the CARE study informed the design and dose selection for the ongoing Phase 3 OPUS program evaluating cenerimod in SLE patients.

Nxera Pharma Initiates Phase 3 Trial of Daridorexant for Insomnia in South Korea

6 months ago

• Nxera Pharma has enrolled the first patient in a Phase 3 clinical trial in South Korea to evaluate daridorexant for treating insomnia. • The trial aims to secure marketing authorization from South Korea's Ministry of Food and Drug Safety, with results expected in 1H 2026. • Daridorexant, approved in Japan as QUVIVIQ™, is already available in the US, Europe and Japan, targeting overactive wake signaling in insomnia. • Insomnia affects 15-25% of South Korean adults, highlighting the need for effective treatments like daridorexant to improve sleep quality.

Cenerimod Demonstrates Reduced Interferon Signatures in Phase 2b SLE Trial

6 months ago

• Cenerimod 4 mg significantly reduced interferon (IFN)-associated protein and gene signature biomarkers in SLE patients after 6 months compared to placebo. • The 4 mg dose showed a more pronounced effect on IFN-1, IFN-γ, and plasma cell biomarkers compared to the 2 mg dose. • Cenerimod 4 mg prevented the transition from low to high IFN-1 status in patients with SLE, indicating a potential disease-modifying effect. • The findings support the rationale for using cenerimod 4 mg in Phase 3 clinical trials for moderate to severe SLE.

UCB and Biogen's Dapirolizumab Pegol Shows Promise in Phase 3 Lupus Trial

8 months ago

• UCB and Biogen's dapirolizumab pegol met the primary endpoint in a Phase 3 trial for moderate-to-severe systemic lupus erythematosus (SLE). • The drug demonstrated significant clinical improvement in disease activity compared to placebo when added to standard of care. • A second Phase 3 trial, PHOENYCS FLY, is planned to further evaluate the efficacy and safety of dapirolizumab pegol in SLE patients. • Dapirolizumab pegol targets the CD40L pathway, offering a novel approach to reduce B cell activation and autoantibody production in SLE.

Viatris Expands Pipeline with Idorsia Collaboration, Focuses on Cardiovascular and Autoimmune Therapies

a year ago

• Viatris collaborates with Idorsia Ltd., acquiring rights to selatogrel for acute myocardial infarction and cenerimod for systemic lupus erythematosus. • Selatogrel is a self-administered medicine for heart attack patients, complementing Viatris' cardiovascular expertise. • Cenerimod, a novel immunology asset, targets systemic lupus erythematosus and may expand to other autoimmune indications. • Viatris' Q4 2023 earnings missed estimates, but key brands like Yupelri and Lipitor showed growth, and new generics contributed $107 million in revenue.