A late-breaking oral presentation demonstrated that cenerimod appears to be safe and well-tolerated in treating Japanese patients with moderate to severe systemic lupus erythematosus (SLE).
The data show clinically meaningful improvements in disease activity, consistent with results from other global Phase 2 trials of cenerimod.
PITTSBURGH, Aug. 23, 2024 /PRNewswire/ — Viatris Inc. (NASDAQ: VTRS), a global healthcare company, today announced results from a Phase 2 study* of cenerimod (ACT-333441). The ACT-333441 study was accepted as a late-breaking abstract and presented during an oral presentation at the 26th Asian Pacific League of Colleges of Rheumatology (APLAR) Annual Congress, which will take place August 21-25, 2024 at Suntec in Singapore.
ACT-333441 was a randomized, double-blind, parallel-group, multicenter, phase 2 study conducted in Japan to evaluate the safety, pharmacodynamics (PD), and efficacy of cenelimod, a selective S1P1 receptor modulator, in 17 Japanese patients with moderate to severe systemic lupus erythematosus (SLE). Adult patients receiving background treatment for SLE were equally randomized to receive either cenelimod 2 mg or 4 mg (administered orally once daily). The primary endpoint of the study measured safety and tolerability, secondary endpoints measured changes in total lymphocyte count, and efficacy was assessed using the modified SLEDAI-2K (mSLEDAI-2K) score.
Both doses of cenelimod appeared to be safe and well tolerated. As expected given cenelimod's mechanism of action, both the 2 mg and 4 mg doses produced reductions in lymphocyte counts that were reversible upon treatment discontinuation. Both doses produced clinically meaningful improvements in disease activity, as measured by mSLEDAI-2K, that were sustained long-term after treatment cessation and were higher with the 4 mg dose. These results are generally consistent with findings from the global Phase 2 CARE trial*.
Visit Viatris at Booth #21-23 at APLAR to learn more about this study and how the company continues to support the needs of the SLE community. Data were presented in the following oral presentations:
Cenerimod in Japanese patients with moderate to severe systemic lupus erythematosus (SLE): A phase 2 randomized double-blind study Speaker: Sharavan Kanagaratnam August 23, 3:00pm-4:15:00pm GMT+8 Abstract Session 3: Late-breaking Abstracts: Systemic Lupus Erythematosus
More information about the APLAR program can be accessed online here
About SLE
Systemic lupus erythematosus (SLE), the most common form of lupus erythematosus, is an autoimmune disease. Although the cause of SLE is not fully understood, T and B lymphocytes are thought to be the key immune cells involved in the pathogenesis of SLE. In patients with SLE, both T and B cells become overactivated and infiltrate various tissues to produce autoantibodies, leading to inflammation and organ damage.
About Senerimod
Cenelimod is an investigational, highly selective S1P1 receptor modulator administered as a once-daily oral tablet that may offer a new approach to the treatment of SLE, a disease that has a significant impact on patients and has limited treatment options.
In December 2022, the Oral S1P1 Receptor Modulation in SLE (OPUS) program was initiated. It 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 in addition to background therapy. The primary objective of the program is to evaluate the efficacy of cenerimod 4 mg in reducing disease activity and controlling disease compared to placebo. The primary endpoint is the SRI-4 response at 12 months compared to baseline. Secondary endpoints include the BICLA response at 12 months 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 mucocutaneous symptom (rash, alopecia, mucosal ulcers) response).
The study of cenerimod for the treatment of SLE received Fast Track designation from the U.S. Food and Drug Administration (FDA), a designation intended to facilitate communication and collaboration between the FDA and pharmaceutical companies about medicines that treat serious conditions and fill unmet medical needs.
*About the CARE Study:
CARE is a phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy, safety, and tolerability of cenerimod in patients with moderate to severe systemic lupus erythematosus (SLE). Patients with SLE, mSLEDAI-2K ≥6 and history or presence of ANA or anti-dsDNA positivity, were randomized to receive oral cenerimod (0.5, 1, 2, or 4 mg) or daily PBO. Background SLE medications had to be stable for ≥30 days (corticosteroids ≥15 days) prior to randomization. Study duration was 18 months (M), with two 6-month treatment periods and one 6-month follow-up. After the first 6 months, patients receiving cenerimod 4 mg were re-randomized to cenerimod 2 mg or PBO to evaluate reversibility of lymphopenia and potential withdrawal effects. Of 427 randomized patients, 339 completed 12 months of treatment. The primary endpoint was change from baseline (BL) to M6 in mSLEDAI-2K. Secondary endpoints were improvement in SLE responder index SRI-4 and BILAG-2004. Safety endpoints included adverse events (AEs) and AEs of special interest (AESIs).
About Beatrice
Viatris Inc. (NASDAQ: VTRS) is a global healthcare company uniquely positioned to bridge the traditional gap between generics and branded medicines. We combine the best of both worlds to more comprehensively address the world's healthcare needs. We provide access at scale with a mission to empower people around the world to live healthier lives at every stage of life. Today, we supply high-quality medicines to nearly one billion patients annually around the world, impacting every moment of life, from birth to the end of life, acute to chronic illness. At Viatris, access means deep things with the broadest and most diverse portfolio of medicines, a unique global supply chain that gets more people medicines when and where they need them, and scientific expertise to address some of the world's most persistent health challenges. Headquartered in the United States, Viatris has global centers in Pittsburgh, Shanghai, and Hyderabad, India. For more information, visit viatris.com and investor.viatris.com. Also follow us on LinkedIn, Instagram, YouTube, and LinkedIn. X (Formerly Twitter).
Forward-Looking Statements
This press release contains “forward-looking statements.” These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, among others, statements regarding the results of clinical trials, the most recent oral presentation indicating that cenelimod appears to be safe and well-tolerated for the treatment of Japanese patients with moderate to severe systemic lupus erythematosus (SLE), the data showing clinically meaningful improvements in disease activity consistent with results from other international Phase 2 studies of cenelimod, both doses of cenelimod appear to be safe and well-tolerated, and the reduction in lymphocyte counts observed at both the 2 mg and 4 mg doses, as expected according to the mechanism of action of cenelimod, was reversible upon discontinuation of treatment. Additionally, both doses demonstrated clinically meaningful improvements in disease activity as measured by mSLEDAI-2K, which were sustained long-term following cessation of treatment and were greater at the 4 mg dose. Forward-looking statements are inherently subject to risks and uncertainties, and therefore actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, actions and decisions of healthcare and drug regulatory agencies, changes in U.S. and foreign healthcare and drug laws and regulations, regulatory, legal or other obstacles to Viatris' ability to bring new products to market (including, without limitation, “at-risk” launches), the ability of Viatris or its partners to develop, manufacture and commercialize products, the scope, timing and outcome of ongoing litigation and the impact of such litigation, and the possibility that Viatris may not realize the intended benefits of its strategic initiatives or achieve its intended goals and prospects. the possibility that Viatris will not achieve the intended or expected benefits, targets, prospects, synergies, growth opportunities and operating efficiencies in connection with any divestiture, acquisition or other transaction or restructuring program within the expected time frame or at all, goodwill or impairment charges or other losses in connection with any divestiture or sale of a business or assets, Viatris' failure to achieve its expected or targeted future financial and operating performance and results, the potential impact of public health outbreaks, epidemics and pandemics, significant breaches of data security or data privacy or disruptions to information technology systems, risks associated with international operations, the ability to protect intellectual property and preserve intellectual property rights, changes in third-party relationships, the impact of changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns, the impact of competition, changes in the economic and financial condition of Viatris or its partners, uncertainties and matters beyond management's control, including general economic conditions, inflation and currency exchange rates, the inability to conduct share repurchases as currently expected, stock price fluctuations, and other risks described in Viatris' filings with the Securities and Exchange Commission (SEC). Viatris routinely uses its website as a means of disseminating material information broadly and on a non-exclusive basis for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements with revisions or changes after the date of this press release, except as required by law.
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