GlobeNewswire/Idorsia to advance cenerimod into -2-

By binding to S1P(1) receptors, a receptor modulator can trigger the internalization of those receptors. This effectively blinds T and B lymphocytes to the S1P gradient, thereby holding them in the lymph nodes and reducing autoreactive T and B cells in the circulation and consequently, also in the tissues.

Following the reduction of circulating T and B cells, it is hypothesized that a reduction in autoantibodies and immune cytokines -- markers of the underlying disease processes -- would also be seen, ultimately further reducing inflammation and tissue damage, key contributors to the disease.

Cenerimod in systemic lupus erythematosus

Cenerimod, the result of 20 years of research in Idorsia's labs, is a highly selective S1P(1) receptor modulator, given as an oral once-daily tablet. Cenerimod potentially offers a novel approach for the treatment of SLE, a disease with a significant impact on patients and limited treatment options.

In a mouse model of SLE, mice typically develop an aggressive version of a lupus-like disease, with increased inflammation, autoantibodies and immune cytokines, resulting in damage to the kidney and death. When treated with cenerimod, an increase in survival was observed. This was underpinned by improved kidney structure and function, as well as marked decreases in important key markers of disease.

The effect of cenerimod on lymphocyte trafficking was confirmed in humans when administration of cenerimod induced a dose-dependent, sustained, and reversible reduction in circulating lymphocyte count.

In a Phase 2 proof-of-concept study investigating the effect of cenerimod on circulating lymphocytes, disease activity, safety, and pharmacokinetics in patients with SLE, cenerimod dose dependently reduced total lymphocyte count from baseline to end of treatment (p<0.001). In addition, the antibody-producing B cells, which are elevated in patients with SLE and critical to disease progression, were markedly reduced by cenerimod. Cenerimod was well tolerated at all dose levels. The occurrence of adverse events was similar in all five treatment groups.

Key Literature

   -- Hermann V, et al. First use of cenerimod, a selective S1P1 receptor 
      modulator, for the treatment of SLE: a double-blind, randomised, 
      placebo-controlled, proof-of-concept study. Lupus Sci Med. 
      2019;6:e000354. 
 
   -- Juif P, et al. Pharmacokinetics and Pharmacodynamics of Cenerimod, A 
      Selective S1P 1 R Modulator, Are Not Affected by Ethnicity in Healthy 
      Asian and White Subjects. Clin Transl Sci. 2021;14:143--7. 
 
   -- Strasser DS, et al. Preclinical to clinical translation of cenerimod, a 
      novel S1P1 receptor modulator, in systemic lupus erythematosus. RMD Open. 
      2020;6:e001261. 
 
   -- Piali L, et al. Cenerimod, a novel selective S1P1 receptor modulator with 
      unique signaling properties. Pharmacol Res Perspect. 2017;5:e00370. 
 
   -- McGinley MP, et al. Sphingosine 1-phosphate receptor modulators in 
      multiple sclerosis and other conditions. Lancet. 2021;398:1184-1194. 
 
   -- Lasa JS, et al. Safety of S1P Modulators in Patients with Immune-Mediated 
      Diseases: A Systematic Review and Meta-Analysis. Drug Saf. 
      2021;44:645-660. 
 
   -- Stepanovska B, et al. Targeting the S1P receptor signaling pathways as a 
      promising approach for treatment of autoimmune and inflammatory diseases. 
      Pharmacol Res. 2020;154:104170. 
 
   -- Barber MRW, et al. Global epidemiology of systemic lupus erythematosus. 
      Nat Rev Rheumatol. 2021;17:515-532. 
 
   -- Kaul A, Gordon, et al. Systemic lupus erythematosus. Nat Rev Dis Primers. 
      2016;2:16039. 
 
   -- Davis LS, et al. Research and therapeutics--traditional and emerging 
      therapies in systemic lupus erythematosus. Rheumatol. 2017;56:i100-i113. 
 
   -- Birt JA, et al. Patient Experiences, Satisfaction, and Expectations with 
      Current Systemic Lupus Erythematosus Treatment: Results of the SLE-UPDATE 
      Survey. Rheumatol Ther. 2021;8:1189-1205. 
 
   -- Tse K, et al. The ALPHA Project: Establishing consensus and 
      prioritisation of global community recommendations to address major 
      challenges in lupus diagnosis, care, treatment and research. Lupus Sci 
      Med. 2021;8:e000433. 

About Idorsia

Idorsia Ltd is reaching out for more -- We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core.

Headquartered near Basel, Switzerland -- a European biotech-hub -- Idorsia is specialized in the discovery, development, and commercialization of small molecules to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team of professionals covering all disciplines from bench to bedside, state-of-the-art facilities, and a strong balance sheet -- the ideal constellation to translate R&D efforts into business success.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 1000 highly qualified specialists dedicated to realizing our ambitious targets.

For further information, please contact

Andrew C. Weiss

Senior Vice President, Head of Investor Relations & Corporate Communications

Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil

[phone]

[e-mail]

[e-mail]

www.idorsia.com

The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.

Anhang

   -- Medienmitteilung PDF 
      https://ml-eu.globenewswire.com/Resource/Download/8f0f0a75-c322-4c63-9c43-774a9b5be45c

(END) Dow Jones Newswires

November 01, 2021 02:00 ET (06:00 GMT)