Biotest AG: Biotest: Monoclonal antibody BT-061 in combination with methotrexate demonstrates good efficacy in Rheumatoid Arthritis
Biotest AG / Key word(s): Miscellaneous
22.03.2011 / 14:28
Biotest: Monoclonal antibody BT-061 in combination with methotrexate
demonstrates good efficacy in Rheumatoid Arthritis
A further phase II trial of BT-061 in Rheumatoid Arthritis concluded
Preliminary analysis shows good clinical efficacy also in combination
with the disease-modifying drug methotrexate
Effective dose range confirmed after subcutaneous administration of
BT-061
First patients have been recruited in a phase IIb trial
Dreieich, March 22, 2011. The clinical part of a phase II trial, in which
the monoclonal antibody BT 061 was tested in combination with the
disease-modifying drug methotrexate for the treatment of Rheumatoid
Arthritis, has now been concluded.
In the double-blind, placebo-controlled, multicentre, multinational phase
II trial, BT-061 was investigated for its efficacy and tolerability in the
treatment of moderate to severe Rheumatoid Arthritis. The trial included
patients who had already been treated with at least one DMARD
(disease-modifying antirheumatic drug) but showed an inadequate response to
this antirheumatic drug.
Biotest previously published interim data from the first part of this
trial, which showed good efficacy and good tolerability after intravenous
administration of BT-061.
In the second part of the trial, which has now been concluded, 30 patients
were treated for eight weeks with weekly subcutaneous administration of 50
mg BT-061 in combination with methotrexate. Eleven patients in the placebo
group were treated with methotrexate only. In a preliminary analysis, the
response rate of the patients was assessed in week nine (after eight weeks
of treatment) on the basis of the ACR score, an internationally accepted
standard evaluation method of the American College of Rheumatology (ACR).
After this eight-week treatment already, the symptoms improved by at least
50% (ACR 50) in 26% of the patients who completed the full treatment cycle
according to the protocol. An improvement of the symptoms by more than 70%
(ACR 70) was observed in 9% of the patients treated with BT-061.
Improvements of 10% and 0% respectively (ACR 50/70) were obtained in the
placebo group.
The good tolerability of BT-061, which was expected based on the data from
previous trials, has also been confirmed in the concluded phase II trial.
'We are very pleased to announce the conclusion of the phase II trial',
commented Dr. Frank Osterroth, Head of Biotherapeutic segment at Biotest.
'When therapeutic agents in Rheumatoid Arthritis are assessed, marked
improvements in symptoms, as measured by the ACR 50 and ACR 70 scores, are
particularly important. The fact that these two parameters show
comparatively positive scores after only eight weeks of treatment again
indicates the high potential of the immunomodulatory mechanism of BT-061.
We anticipate that the efficacy will be further improved in the course of
further clinical development by optimising the dose regimen and
particularly by extending the duration of treatment.'
The extent of symptom improvement as measured by the ACR score depends on
the duration of treatment with all therapies. Maximum response rates,
especially in the ACR 50 and ACR 70 scores, are usually achieved after four
to six months of therapy.
Comparatively high ACR 50 and ACR 70 scores were achieved with BT-061 after
the relatively short treatment duration of only eight weeks. A further
increase in efficacy is expected due to further optimisation of the dose,
frequency of administration and particularly by extending the duration of
treatment.
Based on the interim analysis of this trial after intravenous
administration of BT-061, a corresponding confirmatory phase IIb trial in
Rheumatoid Arthritis was initiated with 176 patients. The duration of
treatment will for the first time be 12 weeks. The first patients have
already been included in this trial.
About BT-061
BT-061 strengthens a natural function of the body that prevents excessive
immune reactions. It is being developed to treat diseases due to an
overreaction of the immune system.
About rheumatoid arthritis
Rheumatoid arthritis is a progressive inflammatory autoimmune disease that
affects joints and organs. It is estimated that about 5 million people
worldwide suffer from RA, with between 0.3 % and 1 % of the population of
industrialised countries affected. The disease occurs three times more
often in women than in men. Although RA can affect people of all age
groups, the disease in most cases occurs between the ages of 25 and 55
years.
Traditional treatment methods against rheumatoid arthritis include
nonsteroidal anti-inflammatory drugs (NSAIDs)), corticosteroids and
disease-modifying antirheumatic drugs (DMARDs). Treatments based on
biotechnology preparations have been added recently.
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-Bremen, Düsseldorf, Hamburg, München, Stuttgart
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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
Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, Hamburg, Stuttgart
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