BBI-6000 is a novel retinoic acid-related orphan nuclear receptor gamma (RORγ) antagonist we are developing as a potential topical product for mild-to-moderate psoriasis. We intend to complete the required IND-enabling studies in 2017 and plan to initiate a proof-of-concept clinical trial in patients with mild-to-moderate psoriasis by the end of 2017 or early in 2018.
RORγ inhibition targets the pathway of a validated cytokine (IL-17) that has been implicated in the pathogenesis of psoriasis. Monoclonal antibodies targeting IL-17 have recently shown significant efficacy in the treatment of psoriasis, and we are planning to develop BBI-6000 as a topically applied, potent and selective small-molecule therapeutic targeting this pathway.
RORγ plays a key role in the immune system. RORγ is involved in converting certain immune cells into pro-inflammatory Th17 cells, which produce cytokines (such as IL-17) that result in inflammation in living organisms. RORγ inhibitors can help to reduce inflammatory conditions by reducing the formation of Th17 cells as well as the release of pro-inflammatory cytokines. This mechanism is believed to have potential against a wide range of autoimmune diseases, such as psoriasis, inflammatory bowel disease, arthritis and multiple sclerosis.