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 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]

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 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]

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]

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]

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]

Further interim analyses confirm good clinical efficacy...

07.07.2009, News

Further interim analyses confirm good clinical efficacy of the BT-061 monoclonal antibody. - Marked improvement in symptoms even after short period of treatment - Over 240 individuals treated ... [More]

Biotest AG:"Focused research, global growth": Biotest i...

22.03.2006,

"Focused research, global growth": Biotest increases its market share worldwide and announces ambitious targets for 2006 Intratect sales to treble by 2007 - high level of demand for ... [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