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 increases revenues by 16,6%

07.05.2015,

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

Biotest Presents New Preclinical Data on Tregalizumab (...

18.11.2014,

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 mono- an ... [More]

Biotest reached an all-time high Profit after Tax

22.03.2012,

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 21.8% vs. the ... [More]

Agreement with Abbott

21.06.2011,

Announcement according to § 15 Sec. 1 Securities Trading Act (WpHG) Dreieich, June 21, 2011 - Abbott and Biotest AG today announced a global agreement to develop and commercialize BT-061, a novel ant ... [More]

Biotest experiences sales growth

08.11.2010,

Biotest experiences sales growth  Sales after nine months 3.5% above the previous year  Performance continues to be affected by the difficult market environment  Board of Management confirms ... [More]

Biotest awarded patent protection in the USA

29.07.2008,

Biotest awarded patent protection in the USA · Patent prosecution for BT-061 successfully completed by US authorities · Decision confirms innovative character of the monoclonal antibody · Compreh ... [More]

Biotest remains on course for growth

10.08.2007,

Biotest remains on course for growth · Clear rise in sales and earnings in the first half of 2007 · Sustained dynamic trend in plasma proteins · Measure to increase earnings in the Diagnostic segmen ... [More]

Biotest achieves further milestones in its monoclonal a...

25.06.2007,

Biotest achieves further milestones in its monoclonal antibody development · Phase I clinical trial confirms good tolerability profile of BT-061. · Start of production for the clinical testing of ... [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