DGAP-News

Biotest AG: Biotest completes recruitment in Phase IIb study (TREAT 2b) of Tregalizumab (BT-061) in patients with rheumatoid arthritis

DGAP-News: Biotest AG / Key word(s): Research Update
Biotest AG: Biotest completes recruitment in Phase IIb study (TREAT
2b) of Tregalizumab (BT-061) in patients with rheumatoid arthritis

09.09.2014 / 16:04

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

PRESS RELEASE

Biotest completes recruitment in Phase IIb study (TREAT 2b)
of Tregalizumab (BT-061) in patients with rheumatoid arthritis

- Biotest's largest and most complex clinical study is running according
to plan

- Patient recruitment completed. More than 300 patients enrolled within
the past ten months


Dreieich, September 9, 2014. Biotest is pleased to announce that the last
patient has been included into the Phase IIb study assessing the efficacy
and safety of tregalizumab (BT-061) in patients with moderate to severe
rheumatoid arthritis. The Phase IIb study also known as TREAT 2b (T cell
REgulating Arthritis Trial 2b) is the largest and most complex Biotest
study to date. The trial is currently underway in 14 countries and more
than 80 study centres in Eastern and Western Europe, the USA, Canada and
Mexico. Treatment of patients in the TREAT 2b study continues as planned.
Therefore the study is on track and Biotest expects, that the assessment of
the endpoints of the study is achieved end of 1st quarter 2015 with
top-line results to be reported in the 2nd quarter 2015.

TREAT 2b study is a double blind, randomised and placebo-controlled trial
with four treatment groups, evaluating the efficacy and safety of
tregalizumab (BT-061) in patients with rheumatoid arthritis. In the active
treatment groups and the main part of the study tregalizumab (BT-061) is
administered at doses of 25, 100 and 200 mg subcutaneously once-weekly for
a treatment duration of 24 weeks given in combination with methotrexate.
Patients in the control arm receive methotrexate only. In patients who
respond to treatment, the therapy can be extended for further six months in
an 'extension phase'. More information can be found on clinicaltrials.gov
(identifier NCT 01999192).

"Biotest is committed to develop and market new medications in areas of
high medical need. The unique mode of action of BT-061 will hopefully open
a new therapeutic option for patients with rheumatoid arthritis and other
autoimmune diseases with high efficacy and good quality of life. This new
drug is developed in close cooperation with medical and scientific key
opinion leaders worldwide," said Prof Gregor Schulz, CEO of Biotest AG. Key