DGAP-News: 4SC Completes Enrolment of the Phase IIb COMPONENT Trial with Vidofludimus in Rheumatoid Arthritis
(firmenpresse) - DGAP-News: 4SC AG / Key word(s): Research Update
4SC Completes Enrolment of the Phase IIb COMPONENT Trial with
Vidofludimus in Rheumatoid Arthritis
20.12.2010 / 07:30
---------------------------------------------------------------------
Planegg-Martinsried, Germany - 20 December, 2010 - 4SC AG (Frankfurt, Prime
Standard: VSC), a drug discovery and development company focused on
autoimmune and cancer indications, today reported that it has completed
enrolment of its COMPONENT Phase IIb study with vidofludimus, an oral
inhibitor of IL-17 release, in rheumatoid arthritis (RA) patients. Data
from the trial are expected to be announced in Q2 2011.
COMPONENT is a randomised, double-blind, placebo-controlled, multi-centre,
international Phase IIb study evaluating the efficacy of vidofludimus in RA
with methotrexate, compared to methotrexate alone. A total of 244 RA
patients were recruited for this trial across 29 clinical trial sites in
Poland, Romania, Bulgaria and the Czech Republic.
'Completion of COMPONENT enrolment is a critical milestone in the
development of vidofludimus and ensures we are on track to see the Phase
IIb outcome in RA for this novel, oral inhibitor of IL-17 release,' said
Ulrich Dauer, CEO of 4SC AG. 'Through the concentrated efforts of
physicians and patients we have jointly been able to explore the efficacy
of vidofludimus in a large population of RA patients on MTX background and
look forward to presenting the data in 2011.'
The recently announced exploratory Phase IIa ENTRANCE trial of vidofludimus
in inflammatory bowel disease met the primary endpoint and achieved a
response rate of 88% in Crohn's disease and ulcerative colitis patients.
-Ends-
About the COMPONENT Study
The COMPONENT trial is a randomised, double-blind, placebo-controlled,
multi-centre, international Phase IIb study, which is evaluating the
efficacy of vidofludimus with methotrexate, compared to methotrexate alone,
in rheumatoid arthritis (RA) patients. The primary endpoint of this study
is the estimation of ACR20, secondary endpoints are ACR50, ACR70, DAS28,
safety parameters and pharmacokinetics. The trial will include 244 patients
in two study arms. The first arm receives 35mg of vidofludimus, once-daily,
plus methotrexate, the second receives placebo plus methotrexate. The study
duration is 13 weeks and eligible patients must have active RA, have
received weekly doses of MTX (10 25 mg/week) for a minimum of 3 months
prior to Day 1 dosing, and have received a stable MTX dose for at least 6
weeks prior to Day 1 dosing.
More information about the COMPONENT trial can be found on
www.clinicaltrials.gov.
About Rheumatoid Arthritis
Rheumatoid Arthritis (RA) is a chronic inflammatory joint disease that
afflicts 0.5 - 1% of the World's population. Women are three times more
likely to get arthritis than men. In the late stage of the disease,
irreversible damage to joint cartilage and bones occurs. Causes of this
disease are genetic as well as autoimmune factors. Aside from
pain-relieving medicines, so-called disease-modifying medicines (DMARDs =
disease modifying anti-rheumatic drugs) can be used in treatment. DMARDs
can be synthetic small molecules or biologicals (for example antibodies).
They differ from other groups of drugs used in the treatment of rheumatoid
diseases, because they are able to stop or reduce damage caused from
chronic inflammation to the joint cartilage or bone. In the most favourable
cases, some DMARDs can also induce repair of joints and provide support for
the repair of changes that have already occurred.
About Vidofludimus
Vidofludimus is a novel, orally administered small molecule for the
treatment of autoimmune disorders such as rheumatoid arthritis and
inflammatory bowel disease. The therapeutic efficacy of vidofludimus is
based on a dual principle. Vidofludimus inhibits the expression of
interleukin-17 (IL-17), a pro-inflammatory cytokine that has a crucial
pathogenic role in a variety of autoimmune diseases. Vidofludimus also
inhibits dihydroorotate dehydrogenase (DHODH), a key enzyme of the
pyrimidine biosynthesis, thereby halting the proliferation of activated T
and B cells which are involved in the pathology of autoimmune disorders.
The combination of two mechanisms of action provides an innovative
therapeutic approach with broad clinical potential in various autoimmune
diseases. Vidofludimus is currently in a Phase IIb study in rheumatoid
arthritis and a Phase IIa study in inflammatory bowel disease.
About 4SC
4SC AG (ISIN DE0005753818) is a drug discovery and development company
focused on autoimmune and cancer indications. Vidofludimus (4SC-101), a
small molecule, is currently in Phase II development in rheumatoid
arthritis and inflammatory bowel disease (IBD), for which positive results
from a Phase IIa study were recently reported. The company's lead oncology
compound, resminostat (4SC-201), a pan-histone deacetylase (HDAC)
inhibitor, is in Phase II trials in hepatocellular carcinoma and Hodgkin's
lymphoma. Two further oncology compounds, 4SC-203 and 4SC-205, are in Phase
I studies. 4SC develops drug candidates until proof-of-concept in order to
generate value creating partnerships with the pharmaceutical industry in
return for advance and milestone payments as well as royalties.
Founded in 1997, 4SC has 94 employees and has been listed on the Prime
Standard of the Frankfurt Stock Exchange since December 2005.
For further information, please visit www.4sc.com.
For more information please contact:
4SC AG
Yvonne Alexander
Investor&Public Relations
Tel.: +49 (0) 89 70 07 63 66
MC Services (Europe)
Raimund Gabriel
Tel.: +49 (0) 89 21 02 28 40
The Trout Group (USA)
Chad Rubin
Tel.: +1 646 378 2947
End of Corporate News
20.12.2010 Dissemination of a Corporate News, transmitted by DGAP - a
company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------
Language: English
Company: 4SC AG
Am Klopferspitz 19a
82152 Martinsried
Deutschland
Phone: +49 (0)89 7007 63-0
Fax: +49 (0)89 7007 63-29
E-mail: public(at)4sc.com
Internet: www.4sc.de
ISIN: DE0005753818
WKN: 575381
Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, München, Stuttgart
End of News DGAP News-Service
---------------------------------------------------------------------
106908 20.12.2010
Datum: 20.12.2010 - 07:30 Uhr
Sprache: Deutsch
News-ID 32897
Anzahl Zeichen: 0
contact information:
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 385 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"DGAP-News: 4SC Completes Enrolment of the Phase IIb COMPONENT Trial with Vidofludimus in Rheumatoid Arthritis"
steht unter der journalistisch-redaktionellen Verantwortung von
4SC AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
