There has been one publication on tregalizumab at the ACR 2015 Annual Meeting in San Francisco. “Tregalizumab (BT-061) is a humanized, anti-CD4 mAb, inducing selective Treg activation in vitro.” It seems an interesting concept, as the authors of the study point out: “Previous trials suggested efficacy in RA at doses ≥25 mg subcutaneously (SC).” But let’s come to the dismal truths of the study.
Ronald F. van Vollenhoven and colleagues presented: “A Phase 2b Study Evaluating the Efficacy and Safety of Subcutaneously Administered Tregalizumab in Subjects with Active Rheumatoid Arthritis (RA) Despite Treatment with Methotrexate (MTX)”. But they had to conclude: “No tested doses of tregalizumab demonstrated significant efficacy improving signs and symptoms of active RA based on ACR20 responses at wk 12 and 24 despite dose dependent down-modulation of CD4 expression. Tregalizumab was generally well tolerated.”
Does this mean, that tregalizumab should be abandoned? I guess not. Maybe Tregs act differently in vivo. And I guess, the team around Ronald F. van Vollenhoven will come out with a new idea, on how to make the concept work. Maybe it only works in a form of combination. Looking forward to new developments with tregalizumab.
van Vollenhoven RF, Keystone EC, Strand V, Pacheco-Tena C, Vencovsky J, Behrens F, Zipp D, Rharbaoui F, Wolter R, Tiemann RD, Knierim L, Schmeidl R, Zhou X, Aigner S, Daelken B, Wartenberg-Demand A. A Phase 2b Study Evaluating the Efficacy and Safety of Subcutaneously Administered Tregalizumab in Subjects with Active Rheumatoid Arthritis (RA) Despite Treatment with Methotrexate (MTX) [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). http://acrabstracts.org/abstract/a-phase-2b-study-evaluating-the-efficacy-and-safety-of-subcutaneously-administered-tregalizumab-in-subjects-with-active-rheumatoid-arthritis-ra-despite-treatment-with-methotrexate-mtx/. Accessed November 19, 2015.