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Late-Breaking oral presentation shows that cenerimod for the treatment of moderate to severe systemic lupus erythematosus (SLE) in Japanese patients can be considered safe and well-tolerated
Data shows a clinically meaningful improvement in disease activity consistent with results from other global Phase 2 studies of cenerimod
PITTSBURGH , Aug. 23, 2024 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS ), a global healthcare company, presented today the results of one of its Phase 2 studies* of cenerimod (ACT-333441). The ACT-333441 study was accepted as a late-breaking abstract and was presented during an oral presentation at the 26 th Asia-Pacific League of Associations for Rheumatology (APLAR) Annual Congress. The congress is being held August 21-25, 2024 , in Suntec, Singapore .
The ACT-333441 study was a randomized, double-blind, parallel-group, multicenter, Phase 2 study that was conducted in Japan and evaluated the safety, pharmacodynamics (PD), and efficacy of cenerimod, a selective S1P 1 receptor modulator, in 17 Japanese patients with moderate to severe systemic lupus erythematosus (SLE). Adult patients receiving SLE background treatment were randomized equally to either 2 mg or 4 mg cenerimod (once-daily, oral dosing). The primary endpoint of the study measured safety and tolerability, and the secondary endpoint measured a change in total lymphocyte count and the efficacy was assessed using a modified SLEDAI-2K (mSLEDAI-2K) score.
Both cenerimod doses were considered safe and well-tolerated. A decrease in lymphocyte counts was observed in both the 2 mg and 4 mg doses as expected per the mechanism of action of cenerimod and was reversible upon treatment discontinuation. Both doses showed a clinically meaningful improvement in disease activity, as measured by mSLEDAI-2K, which persisted long after the treatment was discontinued and was higher with the 4 mg dose. These results are generally consistent with the global Phase 2 CARE study*.
Visit Viatris at APLAR at Booth #21-23 to learn more about the study and how the company continues to support the needs of the SLE community. The data was presented during the following oral presentation:
Further details on the APLAR program can be accessed online here .
About SLE Systemic lupus erythematosus (SLE), the most common form of lupus, is an autoimmune disease. While the cause of SLE is not fully known, T and B lymphocytes are considered the key immune cells that play a role in the development of SLE. In individuals with SLE, both T and B cells become overactive, infiltrate different tissues, and produce autoantibodies, leading to inflammation and organ damage.
About cenerimod Cenerimod is an investigational drug, a highly selective S1P 1 receptor modulator given as an oral once-daily tablet. Cenerimod is an investigational drug that potentially offers a novel approach for the treatment of SLE, a disease with a significant impact on patients and limited treatment options.
In December 2022, the O ral S1 P 1 receptor Mod U lation in S LE (OPUS) program was initiated, which consists of two multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 3 studies to evaluate the efficacy, safety, and tolerability of cenerimod in adult patients with moderate-to-severe SLE on top of background therapy. The main objectives of the program are to evaluate the effectiveness of cenerimod 4 mg in reducing disease activity, as well as controlling the disease, compared to placebo. The primary endpoint is response on SRI-4 at month 12 compared to baseline. Secondary endpoints include response on BICLA at month 12 compared to baseline and measures of sustained disease control: time to first confirmed 4-month sustained mSLEDAI-2K response and time to first confirmed 4-month sustained response in mucocutaneous manifestations (i.e., rash, alopecia, mucosal ulcers).
The investigation of cenerimod for the treatment of SLE has received Fast-Track designation from the U.S. Food and Drug administration (FDA). This designation is intended to promote communication and collaboration between the FDA and pharmaceutical companies for drugs that treat serious conditions and fill an unmet medical need.
*About the CARE study: CARE was a Phase 2b , multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE). Patients with SLE, mSLEDAI-2K ≥6 and history or presence of positive ANA or anti-dsDNA were randomized to daily oral cenerimod (0.5, 1, 2 or 4 mg) or PBO. Background SLE medication had to be stable for ≥30 days pre-randomization (corticosteroids ≥15 days). Study duration was 18 months (M), two 6M treatment periods and a 6M follow-up. After the first 6M , patients on cenerimod 4 mg were rerandomized to cenerimod 2 mg or PBO to assess reversibility of lymphopenia and potential withdrawal effects. Of 427 randomized patients, 339 completed 12M of treatment. The primary endpoint was change from baseline (BL) to M6 in mSLEDAI-2K. Secondary endpoints were SLE Responder Index SRI-4 and BILAG-2004 improvement. Safety endpoints included adverse events (AEs) and AEs of special interest (AESI).
About Viatris Viatris Inc. (NASDAQ: VTRS ) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris. We are headquartered in the U.S., with global centers in Pittsburgh , Shanghai and Hyderabad, India . Learn more at viatris.com and investor.viatris.com , and connect with us on LinkedIn , Instagram , YouTube and X (formerly Twitter).
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