Corporate | 8 June 2011 07:36
4SC AG / Key word(s): Research Update
08.06.2011 / 07:36
Planegg-Martinsried, Germany - June 8, 2011 - 4SC AG (Frankfurt, Prime
Standard: VSC), a discovery and development company of targeted small
molecule drugs for autoimmune diseases and cancer, today announced topline
results from its randomised, double-blind, placebo-controlled Phase IIb
clinical trial COMPONENT in RA. The trial compared vidofludimus, an oral
inhibitor of DHODH and pro-inflammatory cytokines (including IL-17A and
IL-17F as well as INF-gamma), in rheumatoid arthritis patients on
methotrexate background therapy versus methotrexate monotherapy over a
treatment period of 13 weeks.
ACR20 response improvement of the 35 mg vidofludimus group compared to
placebo was statistically significant (p<0.05) at week 2 (16.7% vs.
6.9%) and week 8 (46.7% vs. 31.9%), however, vidofludimus missed the
primary endpoint of significantly improving ACR20 response at week 13
(50.0% vs. 44.8%). Time to ACR20 response was significantly (p<0.05)
shorter in the vidofludimus group compared to placebo (median 56 days vs.
92 days). The patient group treated with vidofludimus also reported higher
ACR50 and ACR70 response rates compared to placebo at week 13.
ACR Efficacy Results at Week 13:
Treatment N ACR20 ACR50 ACR70
35 mg Vidofludimus 120 60 (50.0%) 31 (25.8%) 15 (12.5%)
Placebo 116 52 (44.8%) 20 (17.2%) 7 (6.0%)
*All patients were on stable doses of methotrexate throughout the trial
*Confirmatory analysis of the primary efficacy endpoint (ACR20) has been
performed for all randomized and exposed patients with a minimum of
efficacy data available, i.e., at least one post-baseline efficacy
observation (full analysis set included 236 patients)
Overall, vidofludimus was safe and well tolerated. No obvious differences
in the adverse event rate between the vidofludimus and placebo group were
observed. In particular, there were no relevant increases of diarrhea,
neutropenia, anemia, hypertension, cholesterol or liver enzyme levels. Only
one serious adverse event was reported in the vidofludimus group which was
judged as not being related to vidofludimus. No deaths occurred. These
safety results are consistent with previous Phase IIa trial results in RA
and inflammatory bowel disease (IBD) patients.
'Even though we did not reach the primary efficacy endpoint,' said Dr
Ulrich Dauer, CEO of 4SC AG, 'it is important to note that vidofludimus
demonstrated efficacy in certain secondary parameters and showed very good
tolerability in RA patients. We will continue to evaluate the novel
mechanism of action of vidofludimus and use this new data set as an
opportunity to advance our partnering discussions. We will continue our
efforts for this compound in IBD and potentially other autoimmune
indications such as lupus and psoriasis. Our Phase IIa trial in IBD
achieved an excellent response rate of 88.5% and met the primary endpoint,
both in Crohn's disease and ulcerative colitis patients. We feel this
indication addresses an area of high unmet medical need that continues to
be commercially attractive to potential partners and warrants the further
development of vidofludimus based on the promising trial results.'
- ENDS -
Conference Call
The senior management team of 4SC will host a conference call today at
3.30pm CET (9.30am EST) to inform about the topline results of the
COMPONENT study.
Dial-in numbers:
0800 10 12 072 (Germany)
0800-358-0886 (UK)
1-877-941-1469 (USA)
+49 (0) 6958 999 0805 (other countries)
Conference ID: 4445541
Approximately two hours after the conference call, an audio replay of the
conference will be available on the
'investors/events&presentations/presentations' section of www.4sc.com.
For more information please contact:
4SC AG
Dr Ulrich Dauer, Chief Executive Officer
Tel.: +49 (0) 89 70 07 63 0
Yvonne Alexander, IR & PR
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
Notes to Editor:
About the COMPONENT study
The COMPONENT study is a randomised, double-blind, placebo-controlled,
multi-centre, international Phase IIb study 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 at week 13, secondary endpoints are ACR50, ACR70,
DAS28, safety parameters and pharmacokinetics. The trial enrolled 241
patients in two study arms across 28 sites in Poland, Romania, Bulgaria and
Czech Republic. In the first study arm patients received 35mg of
vidofludimus given orally once-daily plus methotrexate, in the second study
arm patients received placebo plus methotrexate. The study duration was 13
weeks and eligible patients must have had 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 study can be found on
www.clinicaltrials.gov (Identifier NCT01010581).
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 selected
pro-inflammatory cytokines, including interleukin-17 (IL-17A and IL-17F)
and INF-gamma that have crucial pathogenic roles 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. Vidofludimus has completed a successful
Phase IIa trial in inflammatory bowel disease. In addition, various
preclinical models demonstrate the application options of vidofludimus in
further autoimmune indications such as lupus, psoriasis, multiple sclerosis
and transplant rejection.
About 4SC
4SC (ISIN DE0005753818) discovers and develops targeted, small-molecule
drugs for the treatment of diseases with a high unmet medical need in
various autoimmune and cancer indications. These drugs are intended to
provide patients with innovative treatment options that are more tolerable
and efficacious than existing therapies, and provide a better quality of
life. The company's balanced pipeline comprises promising products that are
in various stages of clinical development. 4SC's aim is to generate future
growth and enhance its enterprise value by entering into partnerships with
leading pharmaceutical companies.
Founded in 1997, 4SC currently 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.
Legal Note
This document may contain projections or estimates relating to plans and
objectives relating to our future operations, products, or services; future
financial results; or assumptions underlying or relating to any such
statements; each of which constitutes a forward-looking statement subject
to risks and uncertainties, many of which are beyond our control. Actual
results could differ materially, depending on a number of factors.
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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@4sc.com
Internet: www.4sc.de
ISIN: DE0005753818
WKN: 575381
Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, München, Stuttgart
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