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 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 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]

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 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 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]

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]

Biotest: Significant Increase in Profit after Tax

10.11.2011, News

Biotest: Significant Increase in Profit after Tax - Increase of Profit after tax by 31.1% (Continuing and Discontinued Operations) - Profit after tax contribution of EUR 22 million from sale ... [More]

First time Revenue and EBIT contribution by Biotherapeu...

11.08.2011, News

First time Revenue and EBIT contribution by Biotherapeutics Segment; continuing difficult Plasma Protein Product Environment - Sales increased by 4,9 % in first half of 2011 in continuing ... [More]

Biotest: Monoclonal antibody BT-061 in combination with...

22.03.2011, News

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  ... [More]

Monoclonal antibody BT-061 shows potential in the indic...

21.10.2010, News

Monoclonal antibody BT-061 shows potential in the indication multiple sclerosis - Biotest generates positive pre-clinical data in the indication multiple sclerosis - Further development ... [More]

2009 brings additional growth

19.03.2010, News

2009 brings additional growth - Sales up by 14.1% to EUR440.2 million, EBIT improved by 4.2% - Important progress made in R&E projects - Expanded position as specialist for immunological and ... [More]

Monoclonal antibody BT-061 shows efficacy in the indica...

17.03.2010, News

Monoclonal antibody BT-061 shows efficacy in the indication psoriasis - Final results of Phase I/IIa trial in chronic plaque psoriasis show long- lasting therapeutic effect after a single ... [More]

Biotest increases sales and earnings

05.11.2009, News

Biotest increases sales and earnings - Nine-month figures: sales increase by 12.0%, while EBIT grows by 3.0% - Forecast for the full year 2009 confirmed Dreieich, 5 November 2009. In the first ... [More]

Clinical development of BT-063 started

30.09.2009, News

Clinical development of BT-063 started - Monoclonal antibody for the lead indication systemic lupus erythematosus - Phase I clinical trial with 24 healthy volunteers started - All three ... [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