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GNW-News: Idorsia initiates a multiple-dose efficacy and safety study with cenerimod for the treatment of systemic lupus erythematosus

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07.01.2019 | 07:02

    Idorsia initiates a multiple-dose efficacy and safety study with cenerimod for the treatment of
systemic lupus erythematosus


Idorsia Pharmaceuticals Ltd. /
Idorsia initiates a multiple-dose efficacy and safety study with cenerimod for 
the treatment of systemic lupus erythematosus 
. Verarbeitet und übermittelt durch West Corporation.
Für den Inhalt der Mitteilung ist der Emittent verantwortlich.
Source: Globenewswire


Allschwil, Switzerland - January 7, 2019
Idorsia Ltd (SIX: IDIA) today announced that the first patient has been enrolled
into a multiple-dose study to evaluate the efficacy and safety of cenerimod, a
selective S1P(1) receptor modulator for the treatment of adults with systemic
lupus erythematosus (SLE).

Idorsia is investigating cenerimod, an oral once-daily tablet in patients with
lupus. Cenerimod has the potential to add a distinct mechanism to the treatment
armamentarium for this underserved patient population.

Martine Clozel, MD and Chief Scientific Officer, commented:
"Cenerimod was selected for development due to its unique properties in
experimental models. We believe that a combination of high selectivity for the
S1P(1) receptor and an attenuated calcium response in endothelial cells are
responsible for the excellent preclinical efficacy without bronchoconstrictor or
vasoconstrictor side-effects. SLE was selected as the target indication because
of the pathogenic role of T and B lymphocytes and antibody production in this
disease."

In the Phase 1 program, cenerimod showed marked and sustained circulating
lymphocyte lowering effects. A Phase 2 safety study with cenerimod, which
investigated the pharmacodynamics, safety and tolerability of cenerimod in adult
patients with SLE, has been conducted. The study enrolled 67 patients to receive
either 0.5, 1, 2 or 4 mg/day of cenerimod or placebo over a treatment period of
12 weeks. The results of the study showed that cenerimod induces a dose-
dependent, sustained reduction in circulating lymphocyte counts that was
reversible after treatment discontinuation. Cenerimod was well tolerated at all
dose levels. The occurrence of adverse events was similar in all five treatment
groups.

About the study
Cenerimod is being investigated in a multiple-dose study to evaluate its
efficacy and safety 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 4mg
once-daily orally or placebo for up to 12 months. Patients will receive study
treatment in addition to background SLE therapy. The study aims to validate the
appropriate dose, patient population and endpoints for further development in
SLE.

Guy Braunstein, MD and Head of Global Clinical Development, commented:

"This study is based on a clinical pharmacology program in healthy volunteers
and a Phase 2 safety study in patients with lupus, which showed that cenerimod
reduced circulating lymphocytes in a dose-dependent manner and was safe and well
tolerated at doses up to 4 mg. It has been designed to include input from health
authorities. As background therapy may confound the treatment effect, the
protocol recommends keeping SLE medications as stable as possible during the
double-blind treatment period. The study also considers important patient
perspectives, such as the overall quality of life and debilitating symptoms like
fatigue."


Notes to the editor

About systemic lupus erythematosus
SLE - known more simply as "lupus" since it is the most common form of lupus -
is an autoimmune disease, which means that the body's immune system malfunctions
and attacks the body's own tissues, causing inflammation and organ damage. Some
autoimmune diseases affect individual organs, but in the case of lupus, most
parts of the body can be affected: most commonly the skin, joints, gut, blood
cells, and lungs, as well as the brain, heart, and kidneys.

Lupus can range from mild to life-threatening and can randomly become worse (so-
called 'flare ups') and then better again, which can make living with lupus
unpredictable and its impact on day-to-day life wide-ranging. Around five
million people worldwide have a form of lupus and while it affects people of all
races, genders, and ages, as much as ninety percent of diagnosed cases are in
women. The condition is also more common in people of Afro-Caribbean and Asian
origin compared to Caucasians and is likely to affect these ethnic groups more
severely.

There is no cure for lupus. Most people with lupus are prescribed a combination
of different medications including anti-inflammatory, anti-malarial drugs,
corticosteroids, immunomodulators.

About cenerimod in systemic lupus erythematosus
How and why lupus affects the immune system's defense mechanisms is still not
fully understood. However, T and B lymphocytes are considered the key immune
system cells that contribute to the symptoms of the disease, because their
normal development and mechanism for developing tolerance to the body's own
tissues has malfunctioned in lupus.

T and B lymphocytes have receptors on the surface called "Sphingosine-1-
phosphate receptor 1" (S1P(1)). This receptor senses the gradient of
sphingosine-1-phosphate or S1P, which is high in blood, guiding the lymphocytes
out of lymph nodes towards the circulation.

Cenerimod, a selective S1P(1) receptor modulator, binds to the S1P(1) receptor
on the surface of T and B lymphocytes. This interaction leads to internalization
of the S1P(1) receptor, so that the lymphocyte can no longer sense S1P. As a
result, the lymphocytes are held in the lymph nodes, reducing the availability
of these key players in inflammation to the affected organs and tissues. The
effect of cenerimod on lymphocyte trafficking is reflected by the dose-
dependent, sustained and reversible reduction in circulating lymphocyte counts
observed upon administration of cenerimod.

Key scientific literature
1.        Piali L, et al. Pharmacol Res Perspect. 2017
Dec;5(6).
2.        Borchers AT, et al. Autoimmun Rev. 2010;
9(5):A277-87.
3.        Pons-Estel GJ, et al. Semin Arthritis Rheum. 2010;
39(4):257-68.
4.        Govoni M, et al. Lupus. 2006; 15:110-113.
5.        Rahman A, Isenberg DA. N Engl J Med. 2008;
358:929-39.
6.        Abu-Shakra M, et al. J Rheumatol 1995;
22(7):1259-64.

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 700 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.

Medienmitteilung PDF: 
http://hugin.info/174259/R/2230488/876452.pdf



This announcement is distributed by West Corporation on behalf of West Corporation clients.
The issuer of this announcement warrants that they are solely responsible for the content,
accuracy and originality of the information contained therein.
    
Source: Idorsia Pharmaceuticals Ltd. via GlobeNewswire






© dpa-AFX 2019
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