Biotest AG: Tregalizumab (BT-061) shows efficacy in Chronic Plaque Psoriasis
Biotest AG / Key word(s): Miscellaneous
24.11.2011 / 12:18
---------------------------------------------------------------------
Tregalizumab (BT-061) shows efficacy in Chronic Plaque Psoriasis
Final results of the first repeated dose phase II trial in Chronic
Plaque Psoriasis show efficacy in the higher subcutaneous dose groups
Good tolerability confirmed
Further development in Psoriasis will be based on results of larger
clinical trials in Rheumatoid Arthritis
Dreieich, 24 November 2011. In its collaboration with Abbott, Biotest AG is
pursuing an innovative therapeutic strategy to treat the autoimmune
disorders Rheumatoid Arthritis and Chronic Plaque Psoriasis using the
monoclonal antibody Tregalizumab (BT-061).
A phase IIa clinical trial with repeated doses has been completed in which
Tregalizumab was tested for the treatment of chronic plaque psoriasis.
This trial was a placebo-controlled, double-blind, multicentre,
multinational, multiple dose, dose-escalation study to evaluate the safety
and efficacy of BT-061 in different doses and mode of administrations.
Patients were treated subcutaneously or intravenously weekly for eight
consecutive weeks in six different escalating dose groups. The primary
endpoint of the study was PASI 75 (PASI = Psoriasis Area and Severity
Index) response at Week 9, with PASI 50 and PASI 90 responses at Week 9 as
secondary endpoints.
49 patients with Chronic Plaque Psoriasis were enrolled. Patients received
Tregalizumab as monotherapy at doses between 25-100 mg as subcutaneous
injections or 0.5 and 2 mg as intravenous infusions. Tregalizumab was
administered once weekly for 8 weeks. In each treatment group, six patients
received active treatment and two patients received placebo. After the
treatment period, the patients were observed for further 12 weeks without
Tregalizumab treatment (follow-up period).
Highest clinical response measured by the PASI score was achieved in the
100 mg dose-group. 71.4% of patients experienced at least a 50% improvement
in psoriasis signs and symptoms as measured by PASI (PASI 50) at week 9,
compared with 37.5% of those who received placebo. At the same time, in
this dose-group, 42.9% of patients receiving active drug had an improvement
of at least 75% (PASI 75) vs 12.5% for placebo.
In analogy to the results of the previous Phase I/II trial Study 967
(single dose administration), also in study 973 in the relevant active
dose-groups, the PASI score generally further improved after the end of the
8 week treatment period. Further improvement of up to 90% (PASI 90) was
observed in several patients during the treatment and follow-up period. The
evaluation of response within the treatment and follow-up period (best
response) showed a PASI 50 improvement in 71.4%, a PASI 75 in 57.1% and a
PASI 90 in 14.3% of patients in the 100 mg SC dose-group. The respective
numbers in the corresponding placebo group were 37.5%, 25.0%, and 0.0%
(PASI 50, PASI 75, and PASI 90).
The good tolerability of Tregalizumab, which was expected based on the data
from previous trials, has also been confirmed in the concluded phase IIa
trial.
Further studies in Psoriasis in larger patient groups with a less frequent
dosing schedule and a longer treatment period for Tregalizumab will only be
started after finalisation of phase IIb trials in Rheumatoid Arthritis.
Further information
Tregalizumab (BT-061):
Tregalizumab 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.
Currently, clinical development of Tregalizumab aims at investigating the
clinical efficacy and safety of Tregalizumab in the indications Rheumatoid
Arthritis and Psoriasis. Based on the data obtained so far, promising
efficacy and an overall good safety and tolerability in both lead
indications could be demonstrated. Five clinical trials with Tregalizumab
have been concluded. A confirmatory Phase II trial in Rheumatoid Arthritis
is currently recruiting patients.
Plaque Psoriasis:
Chronic Plaque Psoriasis affects 1-3 % of the population in Europe and
North America and is characterised by an excessive stimulation of growth of
the keratinocytes, the most frequent cell type in the epidermis (the top
layer of the skin). Clinical manifestations comprise large scaly and itchy
patches and redness of the skin. Psoriasis is associated with an increased
prevalence of long-term complications such as Psoriatic Arthritis,
Cardiovascular Diseases or Diabetes.
Psoriasis Area and Severity Index (PASI) is the most widely used tool for
the measurement of severity of psoriasis. PASI combines the assessment of
the severity of lesions and the area affected into a single score.
To make up the score, the three features (redness, thickness, and
scaliness) of psoriatic lesions are each assigned a number from 0 to 4 with
4 being worst. The extent of involvement of each region of the body is
scored from 0 to 6. Adding up the scores give a range of 0 to 72.
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. 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 clinical immunology, haematology and intensive medicine. 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. Biotest has more than 1.600 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
Open Market: Berlin-Bremen, Düsseldorf, Frankfurt, Hamburg, Hannover,
München, Stuttgart
End of Corporate News
---------------------------------------------------------------------
24.11.2011 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.medientreff.de and www.dgap.de
---------------------------------------------------------------------
Language: English
Company: Biotest AG
Landsteinerstraße 5
63303 Dreieich
Germany
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
End of News DGAP News-Service
---------------------------------------------------------------------
147569 24.11.2011
