DGAP-News

Biotest AG: Biotest presents the results of a Phase II study of tregalizumab (BT-061) at the American College of Rheumatology (ACR) Annual Meeting in San Diego

DGAP-News: Biotest AG / Key word(s): Study
Biotest AG: Biotest presents the results of a Phase II study of
tregalizumab (BT-061) at the American College of Rheumatology (ACR)
Annual Meeting in San Diego

28.10.2013 / 16:30

---------------------------------------------------------------------

/
Biotest presents the results of a Phase II study of tregalizumab (BT-061)
at the American College of Rheumatology (ACR) Annual Meeting in San Diego

- Good Efficacy and safety data of previous trials confirmed

- The study protocol of a new Phase IIb study (TREAT 2b) has been
approved in several countries


Dreieich/ Germany, October 28, 2013. Biotest AG today announced the
presentation of efficacy and safety results from the Phase II study '979'
at the Annual Meeting of the American College of Rheumatology (ACR) in San
Diego, United States. The development of tregalizumab (BT-061), an antibody
that selectively activates regulatory T cells, is an innovative and
promising strategy for the treatment of rheumatoid arthritis. Biotest AG is
undertaking the scientific and clinical evaluation of tregalizumab (BT-061)
in collaboration with AbbVie.

Study 979 was a randomized, multi-centre, placebo-controlled study to
investigate the safety and efficacy of tregalizumab (BT-061) in patients
with moderate to severe rheumatoid arthritis who had an inadequate response
to methotrexate. Patients were treated with tregalizumab (BT-061) for 12
weeks in three different dose groups (25, 50, 75 mg), each by subcutaneous
administration once-weekly in combination with methotrexate. The control
group received methotrexate and placebo. At the end of the treatment
period, change in disease was assessed using the following clinical
parameters:

CDAI (Clinical Disease Activity Index), SDAI (Simple Disease Activity
Index), ACR 20/50/70, and individual components of the ACR score, e.g.
number of swollen and tender joints.

At the beginning of the study, almost all patients had highly active
disease. After 12 weeks of treatment with tregalizumab (BT-061), patients
showed marked improvements of the CDAI score. In the best dose group, 37.5
% of patients had low disease activity and 3.1% were in remission. In the
placebo group 3.1% and 0% of patients had low disease activity or
remission, respectively.

ACR 20 responses (improvement of disease activity by at least 20%) were
observed in up to 56% of patients treated with tregalizumab, and up to 37%
and 7% of patients had improvements of disease activity of 50% (ACR 50) or
70% (ACR 70) respectively. The good tolerability of tregalizumab (BT-061)
observed in previous trials was also confirmed in this trial.