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Idorsia Pharmaceuticals Ltd (0RQE)

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Wednesday 02 October, 2019

Idorsia Pharmaceuticals Ltd

Data on cenerimod – Idorsia's S1P1 receptor modulator – will be presented at the ACR / ARP Annual Meeting 2019

Data on cenerimod – Idorsia's S1P1 receptor modulator – will be presented at the ACR / ARP Annual Meeting 2019

Allschwil, Switzerland – October 2, 2019 

Idorsia Ltd (SIX: IDIA) today announced that data from a Phase 2 study with cenerimod, a selective sphingosine-1-phosphate 1 (S1P1) receptor modulator, will be shared during the American College of Rheumatology (ACR) / Association for Rheumatology Professionals (ARP) Annual Meeting 2019 in Atlanta, Georgia, US.

An oral presentation entitled "First Use of Cenerimod, a Selective sphingosine-1-phosphate 1 (S1P1) Receptor Modulator, for the Treatment of Systemic Lupus Erythematosus: A Double-Blind, Randomised, Placebo-Controlled, Phase II, Proof-of-Concept Study", will be part of the "3S081: SLE – Clinical I: Clinical Trials (857–862)" session with a focused discussion with the lead author, Viktoria Hermann from Idorsia, at 15:45 on November 10, 2019. The abstract can be found online.

In addition to the Phase 2 data, four poster presentations entitled

  • "Assessment of Fatigue in Adults with Moderate to Severe Systemic Lupus Erythematosus (SLE): A Qualitative Study to Explore the Content Validity of a Fatigue Questionnaire",
  • "Cenerimod, a Potent, Selective and Orally Active Sphingosine 1-phosphate Receptor 1 Modulator, Reduced Blood Antibody-secreting Cells in Patients with SLE",
  • "Cenerimod, a Potent and Selective Sphingosine-1-Phosphate Receptor 1 Modulator, Controls Systemic Autoimmunity and Organ Pathology in Mouse Models of Systemic Lupus Erythematosus and Sjögren’s Syndrome",
  • "In Vitro Characterization of the Effect of Cenerimod, a Potent and Selective Sphingosine 1-Phosphate Receptor 1 (S1P1) Modulator, on S1P1 Receptor Expression, Receptor Internalization, and Migration of Primary Human T cells in the Presence or Absence of Glucocorticoids",

will highlight further results of preclinical, clinical, and qualitative studies with cenerimod. The abstracts can be found online.

Idorsia representatives will be present at booth 1252 from 10:00 - 17:00 on Sunday, November 10, until Tuesday, November 12 (14:30).

Notes to the editor

About cenerimod
Cenerimod is a selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, which potentially offers a novel approach for systemic lupus erythematosus (SLE) – a disease with limited treatment options.

In December 2018, Idorsia initiated a multiple-dose, efficacy and safety study with cenerimod for the treatment of adult patients with moderately to severely active, autoantibody-positive SLE. The multicenter, randomized, double-blind, placebo-controlled, parallel-group study will enroll around 500 patients, who will be randomized into four cenerimod treatment arms: 0.5, 1, 2, and 4 mg once-daily orally or placebo for up to 12 months. Patients will receive study treatment in addition to background SLE therapy, which will be kept as stable as possible to avoid confounding the treatment effect. The study aims to validate the appropriate cenerimod dose, patient population and endpoints for further development in SLE.
In December 2017, the US FDA designated the investigation of cenerimod for the treatment of SLE as a Fast Track development program. The Fast Track designation is intended to promote communication and collaboration between the FDA and the company for drugs that treat serious conditions and fill an unmet medical need.

Cenerimod at ACR-19
Oral presentation:
First Use of Cenerimod, a Selective sphingosine-1-phosphate 1 (S1P1) Receptor Modulator, for the Treatment of Systemic Lupus Erythematosus: A Double-Blind, Randomised, Placebo-Controlled, Phase II, Proof-of-Concept Study.
Session: 3S081: SLE – Clinical I: Clinical Trials (857–862).
Viktoria Hermann1, Anastas Batalov2, Svetlana Smakotina3 and Peter Cornelisse1, 1Idorsia, Allschwil, Switzerland, 2Medical University of Plovdiv, University Hospital Kaspela, Plovdiv, Bulgaria, 3Kemerovo Regional Clinical Hospital, Kemerovo, Russia
Sunday, November 10, 2019, 15:45 - 16:00.

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 one of Europe’s leading biopharmaceutical companies, with a strong scientific core.

Headquartered in Switzerland - a biotech-hub of Europe - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet – the ideal constellation to bringing R&D efforts to business success.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 750 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
+41 (0) 58 844 10 10
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.

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