Development pipeline

Tregalizumab (BT-061)

Tregalizumab (BT-061) is a humanised monoclonal anti-CD4 antibody that selectively activates regulatory T cells (Tregs).

Tregalizumab thus reinforces a natural function of the body to prevent excessive immune reactions. The antibody with this new mechanism of action is being developed for the treatment of autoimmune diseases.

Clinical development of tregalizumab in rheumatoid arthritis was discontinued, after BT-061 did not met primary end-point in a Phase 2b trial. Pre-clinical work is currently ongoing to evaluate the MoA in other diseases.

Press releases

Biotest to present data from TREAT 2b trial at The Ame...

09.11.2015, News

Biotest to present data from TREAT 2b trial at The American College of Rheumatology (ACR) 2015 Annual Meeting - Presentation of clinical results from TREAT 2b trial (T cell REgulating ... [More]

Biotest increases revenues in first half year 2015 by 8...

11.08.2015, News

Biotest increases revenues in first half year 2015 by 8.9% - Clinical development of BT-061 will be discontinued - Capacity expansion at headquarter Dreieich on schedule - Board of ... [More]

Biotest regains rights to Tregalizumab (BT-061)

24.06.2015, News

Biotest regains rights to Tregalizumab (BT-061) - AbbVie exercised its rights to opt-out of the worldwide license, development and commercialisation agreement Dreieich, ... [More]

Biotest increases revenues by 16,6%

07.05.2015, News

Biotest increases revenues by 16,6% - Higher Sales in the US - Capacity expansion at headquarter Dreieich in schedule Dreieich, 7 May 2015. The Biotest Group again succeeded to increase ... [More]

Biotest Phase IIb study of Tregalizumab (BT-061) in mo...

24.04.2015, News

Biotest Phase IIb study of Tregalizumab (BT-061) in moderate to severe rheumatoide Arthritis did not meet the primary endpoint - potential one time effect of up to - EUR 30 million - No safety ... [More]

Biotest Phase IIb study of Tregalizumab (BT-061) in mod...

24.04.2015, Adhoc

Announcement according to § 15 Sec. 1 Securities Trading Act (WpHG) Biotest Phase IIb study of Tregalizumab (BT-061) in moderate to severe rheumatoide Arthritis did not meet the primary endpoint - ... [More]

Biotest Presents New Preclinical Data on Tregalizumab (...

18.11.2014, News

Biotest Presents New Preclinical Data on Tregalizumab (BT-061) at the Annual Meeting of the American College of Rheumatology in Boston - New preclinical results confirm treatment rationale in ... [More]

Biotest increases sales by 11,5% compared to previous y...

12.11.2014, News

Biotest increases sales by 11,5% compared to previous year - Good interim results of R&D projects Civacir(R) and Tregalizumab (BT-061) - Building permission for capacity expansion in ... [More]

Biotest completes recruitment in Phase IIb study (TREAT...

09.09.2014, News

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 ... [More]

Biotest increases revenues by 8,5%

11.08.2014, News

Biotest increases revenues by 8,5% - EBIT increase by 2,3% - Good Progress in the R&D pipeline - Revised outlook Dreieich, August 11, 2014. The Biotest Group was again able to ... [More]

Outlook revised

11.08.2014, Adhoc

Announcement according to § 15 Sec. 1 Securities Trading Act (WpHG) Outlook revised Dreieich, August 11, 2014. The Management Board revises its outlook. A sales increase of 7% and an operating ... [More]

Biotest continues to show a sales increase

07.05.2014, News

Biotest continues to show a sales increase - Sales at EUR 122.2 million (+2.9%) - Progress in CapEx program "Biotest Next Level" - Positive development in R&D projects Dreieich,7 May ... [More]

Biotest increases profit after tax by 38.5 %

25.03.2014, News

Biotest increases profit after tax by 38.5 % - Earnings before interest and tax (EBIT) of the Biotest Group at EUR53.8 million represents an increase of 20.4 % vs. the previous year - ... [More]

Biotest presents the results of a Phase II study of tr...

28.10.2013, News

/ 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 ... [More]

Biotest increases Profit before Tax by 28%

25.03.2013, News

Biotest increases Profit before Tax by 28% - Profit after tax of the Biotest Group (Continuing Operations) at EUR23.1 million represents an increase of 23.5% vs. the previous year - ... [More]

Biotest decides to move into biggest Phase IIb trial in...

21.03.2013, News

Biotest decides to move into biggest Phase IIb trial in company history Dreieich, 21 March 2013. Biotest announced today that Biotest intends to start an additional Phase IIb trial with up to 350 ... [More]

Biotest Group with double digit EBIT growth

13.08.2012, News

Biotest Group with double digit EBIT growth - Sales increase to EUR 220.2 mio. - EBIT increase by 14.5% to EUR 22.9 EUR mio. - Management confirms guidance 2012 Dreieich, 13 August 2012. ... [More]

Biotest Group reports substantially higher EBIT

10.05.2012, News

Biotest Group reports substantially higher EBIT - EBIT up 14.3% at EUR 10.4 million - Sales increased to EUR 107.7 million - Management Board confirms forecast Dreieich, 10 May 2012. The ... [More]

Biotest reached an all-time high Profit after Tax

22.03.2012, News

Biotest reached an all-time high Profit after Tax - Profit after tax of the Biotest Group (Continuing Operations and Discontinued Operation) at EUR48.1 million represents an increase of ... [More]

Tregalizumab (BT-061) shows efficacy in Chronic Plaque ...

24.11.2011, News

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 ... [More]

Publications

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Rharbaoui et al.:Therapeutic Potential of Anti-CD4 Mediated Regulatory T-cell Activation
[ Link ]

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ACR/ARHP Annual Scientific Meeting; November 14-19, 2014, Boston (USA)
PDF, 391.6 kB
[ Download ]

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ACR/ARHP Annual Scientific Meeting, November 9.-14.2012, Washington, D.C., (USA)
PDF, 372.84 kB
[ Download ]

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Helling et al.: A specific CD4 epitope bound by tregalizumab mediates activation of regulatory T cells by a unique signaling pathway. Immunol Cell Biol. 2014 Dec 16. doi: 10.1038/icb.2014.102.
[ Link ]

Clinical trials

Title

Indication

Status

 
Tregalizumab (Study 986) Rheumatoid arthritis Study completed

A 24-week Phase IIb, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Tregalizumab (BT061) in Combination With Methotrexate in the Treatment of Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Alone, Followed by a 24-week Extension Phase: T Cell REgulating Arthritis Trial 2b (TREAT 2b)

Link Clinicaltrial.gov
 
Tregalizumab (Study 979) Rheumatoid arthritis Study completed

A Multi-center, Double-blind, Randomized, Placebo-controlled, Dose-finding Study in Patients With Active Rheumatoid Arthritis Incompletely Controlled on Stable MTX Doses to Investigate Efficacy and Safety of SC BT061

Link clinicaltrials.gov
 
Tregalizumab (Study 971) Rheumatoid arthritis Study completed

A randomized, placebo-controlled, double-blind, dose escalation study to evaluate the efficacy, safety and tolerability of the study drug BT971 in patients with rheumatoid arthritis

Link clinicaltrialsregister.eu
 
Tregalizumab (Study 962) Rheumatoid arthritis Study completed

A randomised, placebo-controlled, double-blind, dose escalation study to evaluate the efficacy, safety, and tolerability of the study drug BT962 (humanised CD4 monoclonal antibody BT061 or placebo) in patients with chronic rheumatoid arthritis

 
Tregalizumab (Study 973) Plaque psoriasis Study completed

A Randomized, Placebo-controlled, Double-blind, Multicentre, Multiple Dose, Cohort Study With Escalating Doses to Evaluate the Safety and Efficacy of the Humanized Monoclonal Antibody BT061 Administered to Patients With Moderate to Severe Chronic Plaque Psoriasis

Link clinicaltrials.gov
 
Tregalizumab (Study 967) Plaque psoriasis Study completed

A randomised placebo-controlled double-blind dose escalation study to evaluate the efficacy, safety and pharmacokinetic properties of the humanised CD4 monoclonal antibody BT061 in patients with chronic plaque psoriasis

 
Tregalizumab (Study 985) Healthy volunteers Study completed

A prospective, open-label, randomized, monocenter, phase I study to investigate pharmacokinetic and pharmacodynamic properties of single SC doses of the humanized monoclonal antibody BT061

 
Tregalizumab (Study 961) Healthy volunteers Study completed

A prospective open-label single-dose study to investigate the safety and tolerability of low doses of the humanised CD4 monoclonal antibody BT061 in healthy volunteers