• New preclinical results confirm treatment rationale in mono- and combination therapy settings
  • Pro-inflammatory cytokines or methotrexate have no negative impact on in vitro activation of regulatory T-cells by Tregalizumab

DREIEICH, Germany I November 18, 2014 I Biotest AG announced that data from in vitro studies on tregalizumab have been presented yesterday at the American College of Rheumatology (ACR) Annual Meeting in Boston, entitled “The Effect of a Pro-Inflammatory Milieu on Tregalizumab (BT-061)-Induced Regulatory T Cell Activity” (Abstract # 1725).

Tregalizumab is an antibody that selectively activates naturally occurring regulatory T cells (Tregs), and is currently in Phase 2b clinical development for the treatment of rheumatoid arthritis (RA). This mode of action is unique and totally different from other treatment modalities currently used in RA. Activating regulatory cells may yield high treatment efficacy with less side effects due to lower over all suppression of the immune system.

The presented in vitro studies examined the potential of tregalizumab to activate regulatory T-cells in the presence of high levels of pro-inflammatory cytokines as observed in patients with autoimmune diseases such as RA. Further investigations focused on the influence of methotrexate which is widely used as co-medication in RA in combination with tregalizumab.

The experiments show that the in vitro activation of regulatory T-cells by tregalizumab is not inhibited either by MTX or by pro-inflammatory cytokines (IL-1ß, IL-6 and TNF-a). The scientific evaluation was done in collaboration with the research group of Dr. Helmut Jonuleit, University of Mainz.

“These findings further increase our understanding on the mode of action of tregalizumab. The data support the therapeutic potential of tregalizumab`s novel mechanism for the treatment of rheumatoid arthritis and other autoimmune diseases, both, in combination with methotrexate or as stand-alone therapeutic“ said Dr. Jörg Schüttrumpf, Head of Research at Biotest AG. “We look forward to reporting the first clinical data from our phase 2b trial in RA (TREAT 2b) in the 2nd quarter of 2015.” TREAT 2b is currently underway in 14 countries, with more than 80 study centers. Patient recruitment was completed in September 2014.

The poster is available online at www.biotest.de.

SOURCE: Biotest