TRB-061

TRB-061 is an investigational biological therapeutic developed by TRexBio. It is a novel, selective agonist of Tumor Necrosis Factor Receptor 2 (TNFR2). The drug’s mechanism of action centers on augmenting the activity and proliferation of tissue-resident regulatory T cells (Tregs), which are key mediators of immune suppression. By expanding Tregs, TRB-061 aims to restore immune homeostasis in inflamed tissues, offering a targeted approach distinct from conventional broad immunosuppression. The primary indications under investigation are moderate-to-severe atopic dermatitis and inflammatory bowel diseases, including ulcerative colitis. Preclinical studies have demonstrated potent in vivo expansion of human Tregs and proof-of-concept efficacy in animal models for colitis and skin inflammation. As of mid-2025, TRB-061 is undergoing Phase 1 clinical trials to assess safety, pharmacokinetics, and pharmacodynamics in healthy volunteers and patients with atopic dermatitis[1][3][4].