Ad-hoc announcement in accordance with §15 WpHG (German Securities Trading
Act)
4SC announces initial results from its Phase IIa clinical study with
SC12267
Planegg-Martinsried, Germany, 29 November 2007 - German drug discovery and
development company 4SC AG (Frankfurt, Prime Standard: VSC), based in
Martinsried near Munich, today completed the first analysis of the results
of the Phase IIa clinical study with SC12267 for the treatment of
rheumatoid arthritis.
In the randomized, double-blind, placebo-controlled study, two groups of
patients were treated over a period of 12 weeks with a daily oral
administration of two different doses of SC12267 (20 mg and 35 mg). Over
the same period of time, another group of patients received a placebo. The
aim of the study was to prove the efficacy, safety and pharmacokinetics of
the drug candidate.
The available study results demonstrate good tolerability and safety for
SC12267. Efficacy was shown depending on selected clinical endpoints and
previous medication of the patients.
To prove efficacy, the so-called DAS28 score for measuring disease activity
and the international established ACR response criteria for assessing
treatment success were defined as clinical endpoints.
In accordance with ACR20-responses (a measure for the reduction of
RA-symptoms of at least 20%) the results over all patients confirmed
dose-dependent trends in efficacy. Results showed that an ACR20 response
was attained in about 47% of patients in the 35-mg group compared to
approximately 33% of patients in the placebo group.
Evaluating the DAS28 score (a tool for the judgement of the disease
activity of RA patients on the basis of 28 defined joints) a reduction was
observed in all three treatment groups after 12 weeks of treatment, but due
to a high placebo response rate the differences in the 20 mg and 35 mg
groups compared to placebo were not conclusive.
Very pronounced was data of patients who had received treatment with other
DMARDs (disease modifying antirheumatic drugs) prior to the trial, and were
now given a 35 mg dose of SC12267. A clear, positive trend in efficacy
could be achieved for all parameters compared to the placebo group.
Patients of this subgroup showed a response-rate of 50% compared to 13% of
the placebo group referring to the ACR20 response.
The final study report is expected within the next weeks after completion
of additional evaluations. 4SC AG will use the available data for further
talks with potential partners in the pharmaceutical industry.
End of ad-hoc announcement
Information and explanations from the issuer about this announcement:
SC12267 is one of six projects of the drug discovery and development
pipeline of 4SC AG. It is a new type of small molecular active agent from
the class of DMARDs used for treatment of autoimmune diseases such as
rheumatoid arthritis or multiple sclerosis.
Prof. Dr. Bernhard Manger of the Institute for Rheumatology and Clinical
Immunology at the Medical Clinic III, University Erlangen-Nurnberg and
principal investigator of the study stressed the positive efficacy of
SC12267 in particular for previous treated patients: “The clear efficacy in
the relevant patient groups is of particular importance for this new drug
candidate. This safety and efficacy data opens up new options for the basic
treatment of rheumatoid arthritis.”
Against this background and in view of the broad therapeutic potential of
SC12267 in other indications as well, 4SC AG is encouraged for its
negotiations with potential pharmaceutical partners regarding an
outlicensing agreement for this project. The broad therapeutic potential of
SC12267 was already underpinned in several preclinical studies for
chronically inflammatory intestinal diseases and inflammatory skin
diseases.
About 4SC AG:
4SC AG (ISIN DE0005753818) has been listed in the Prime Standard of
Frankfurt Stock Exchange since 15 December 2005. Founded in 1997 and now
with a staff of 63, the company develops novel drug candidates for
inflammatory diseases and cancer using a cheminformatics based technology
platform. Traditional high throughput screening of therapeutic agents has
been transferred from the lab to the computer. Thus, the company offers
substantial cost and time advantages as well as increased success rates in
drug development. 4SC AG uses its patented technology platform to create a
sustainable product pipeline for active agents that are developed in early
clinical phases ("proof of concept") and subsequently result in upfront and
milestone payments as well as participation in sales generated by
out-licensed products to the pharmaceutical industry. There are currently
six projects in the pipeline. The first project on the treatment of
rheumatoid arthritis has completed clinical phase IIa. Four other product
candidates are in preclinical development and another project is in the
research stage. Furthermore, the company has its technology platform in
co-operation projects with biotech and pharma companies and is already
generating initial revenues.
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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