Ulcerative colitis (UC) remains incurable, and the goal of any pipeline therapy is still to induce and maintain remission. For over a decade, anti-tumour necrosis factor alpha (TNF-α) drugs have been the mainstay of treatment of moderate to severe UC, despite their drawbacks. However, in more recent years additional mechanisms of action were introduced to the market, including Entyvio, an anti-integrin; Xeljanz, a Janus kinase (JAK) inhibitor; and Stelara, an anti-IL-12 / IL-23, which were FDA-approved in 2014, 2018, and 2019, respectively.
GlobalData has identified nine late-stage pipeline candidates in clinical development for UC. Of the innovative targets, all are immunomodulatory / anti-inflammatory, and several aim to provide mucosal healing and offer an improvement in the maintenance of disease remission over the existing therapies. These agents include a number of biologics and small molecules that target both inflammatory cytokines and their signalling pathways, such as interleukin inhibitors (AbbVie’s Skyrizi [risankizumab], Eli Lilly’s mirikizumab, and J&J’s Tremfya [guselkumab]), integrin and adhesion blockers (Takeda’s Entyvio SC [vedolizumab], a subcutaneous version of an already approved drug, and EA Pharma / Kissei Pharma / Eisai’s carotegrast, in Japan only), sphingosine-1-phosphate (S1P) receptor modulators (BMS’ Zeposia [ozanimod] and Arena’s etrasimod), and JAK inhibitors (Gilead / Galapagos / Eisai’s Jyseleca [filgotinib] and AbbVie’s Rinvoq [upadacitinib]).
Figure 1: Key Phase II / III Trials for the Promising Pipeline Agents that GlobalData Expects to Be Licensed for ulcerative colitis in the 8MM Between 2019 and 2029.
8MM = US, France, Germany, Italy, Spain, UK, Japan, and Canada.