Biotest AG: Immunomodulatory antibody BT-061 shows competitive efficacy in the indication Rheumatoid Arthritis
Biotest AG / Miscellaneous
10.08.2010 10:00
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Immunomodulatory antibody BT-061 shows competitive efficacy in
the indication Rheumatoid Arthritis
- Phase IIa monotherapy trial completed
- Competitive clinical efficacy already after a short treatment period
- Good safety and tolerability profile confirmed
Dreieich, Germany, 10. August 2010. Biotest AG is pleased to announce final
data from a phase IIa clinical trial with its immunomodulatory antibody
BT-061.
In the now completed multicenter, randomised placebo-controlled trial, 96
patients with active Rheumatoid Arthritis with an inadequate response to
therapy with one or more traditional disease-modifying anti-rheumatic drugs
(DMARD) were enrolled. Patients received BT-061 as a monotherapy at doses
between 1.25 -100 mg as subcutaneous injection or 0.5-25 mg as intravenous
infusion or placebo. Treatment was administered once weekly for 6 weeks.
Patients included were randomly assigned to receive either
BT-061 or placebo in a ratio of 3:1. In each dose group, six patients
received active treatment and two patients received placebo.
Safety, tolerability and efficacy of BT-061 were evaluated. During the
clinical trial, progressively higher dosages of the antibody were tested to
identify the most active dose groups for subcutaneous and intravenous
application of BT-061.
Clinical efficacy was evaluated on the basis of the ACR score, the
internationally accepted standard rating system developed by the American
College of Rheumatology.
Already after the short treatment cycle with BT-061 of only six weeks
(evaluation week 7), in the most active subcutaneous dose group (50 mg),
symptoms improved by at least 20% (ACR 20 response) in 67% of the patients,
compared to 14% of the placebo group. An amelioration of parameters of at
least 50% (ACR 50 response) was recorded for 33% of patients, and 17% of
patients showed an improvement of symptoms of more than 70% (ACR 70
response). In the placebo group, the relevant values were 7% for ACR 50 and
0% for ACR 70.
The efficacious dose range for subcutaneous administration could be
determined between 25 and 100 mg.
'We are pleased to announce the completion of this phase IIa clinical trial
and the promising efficacy data we obtained. In particular we are
encouraged that despite the very short treatment cycle the obtained results
look promising in comparison to the currently available gold standard for
biologic therapy of Rheumatoid Arthritis. The
completion of this trial is of particular importance to further support our
ongoing discussions with potential strategic partners towards a global
collaboration.' stated Prof. Schulz, CEO Biotest AG.
In the concluded trial, no major safety signals have been identified and an
overall good safety profile could be demonstrated. Detailed results from
this study will be presented on international scientific congresses.
Currently, two clinical trials are ongoing in order to investigate the
clinical efficacy and safety of BT- 061 in the lead indications Rheumatoid
Arthritis and Chronic Plaque Psoriasis. Up to now 350 subjects have been
enrolled in BT-061 studies. So far, BT-061 demonstrates promising efficacy
and an overall good safety and tolerability in both lead indications. The
data from this trial triggered the transition to a later stage of
clinical development of BT-061. A new phase IIb trial (175 patients) with
the goal to establish the statistical basis for pivotal testing has been
initiated in August.
About BT-061
BT-061 enhances a natural mechanism of down regulating excessive immune
responses and is therefore developed to treat disease conditions that
originate from an overreaction of the immune system.
About Rheumatoid Arthritis
Rheumatoid Arthritis is a progressive autoimmune disease that causes
chronic inflammation of the joints. It is estimated that five million
people suffer from RA globally with 0.3 % to 1 % of the population in
industrialized countries suffering from the disease. Women are three times
more likely to be affected than men. Although it can affect people of all
ages, the onset of RA usually occurs between the ages of 35-55.
Traditional treatments for RA include nonsteroidal anti-inflammatory drugs
(NSAIDs),corticosteroids and disease-modifying antirheumatic drugs
(DMARDs), with biological therapies a more recent addition.
Disclaimer
This document contains forward-looking statements on overall economic
development as well as on the business, earnings, financial and assets
position of Biotest AG and its subsidiaries. These statements are
based on current plans, estimates, forecasts and expectations of the
company and are thus subject to risks and elements of uncertainty that
could result in significant deviation of actual developments from expected
developments. The forward-looking statements are only valid at the time of
publication. Biotest does not intend to update the forward-looking
statements and assumes no obligation to do so.
About Biotest
Biotest is a provider of pharmaceutical and biotherapeutic drugs as well as
reagents and systems for microbiology. With a value added chain that
extends from pre-clinical and clinical development to worldwide
sales, Biotest has specialised primarily in the areas of application of
immunology and haematology. In its Plasma Protein segment, Biotest develops
and markets immunoglobulins, coagulation factors and albumins
based on human blood plasma. These are used for diseases of the immune and
haematopoietic systems. In the Biotherapeutic segment, Biotest researches
into the clinical development of monoclonal antibodies, including in the
indications of rheumatoid arthritis and cancer of plasma cells. The
products of the Microbiological Monitoring segment are primarily used in
hygiene monitoring. Biotest has more than 1,900 employees worldwide. The
preference shares of Biotest AG are listed in the SDAX on the Frankfurt
stock exchange.
Biotest AG, Landsteinerstr. 5, D-63303 Dreieich, www.biotest.de
Dr. Monika Buttkereit
tel.: +49 (0) 6103 801-4406,
e-mail: investor_relations@biotest.de
fax: +49 (0) 6103 801-347
Securities' ID No., ISIN ordinary shares: 522720, DE0005227201
Securities' ID No., ISIN preference shares: 522723, DE0005227235
Listing: Prime Standard/regulated market
Frankfurt, Berlin, Düsseldorf, Hamburg, Stuttgart
10.08.2010 Ad hoc announcement, Financial News and Press Release distributed by DGAP.
Media archive at www.medientreff.de and www.dgap.de
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Language: English
Company: Biotest AG
Landsteinerstraße 5
63303 Dreieich
Deutschland
Phone: 0 61 03 - 8 01-0
Fax: 0 61 03 - 8 01-150
E-mail: investor_relations@biotest.de
Internet: http://www.biotest.de
ISIN: DE0005227235, DE0005227201
WKN: 522723, 522720
Indices: SDAX
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Hamburg, Berlin, Düsseldorf, Stuttgart
End of News DGAP News-Service
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