The ulcerative colitis (UC) treatment pipeline is flush with promising therapies, with over 13 agents in either Phase IIb or III development. Many of these agents are in the later stages of development and have promising novel mechanisms of action (MOAs) and new routes of administration, which will ultimately provide more treatment options for patients in the coming years, says GlobalData, a leading data analytics company.

UC is an inflammatory bowel disease characterized by inflammation and ulcers in the large intestine, often causing symptoms that impact a patient’s quality of life including diarrhea, abdominal pain, cramping, fatigue, weight loss, and pain.

Garrett Towler, Pharma Analyst at GlobalData, comments: “Although there are numerous agents already indicated for UC with a range of MOAs, the current late-stage pipeline remains quite strong with multiple novel MOAs and routes of administration. This includes agents such as Abivax’s obefazimod; InDex Pharmaceuticals’ cobitolimod; three interleukin-23 (IL-23) inhibitors, AbbVie’s Skyrizi (risankizumab), Eli Lilly’s mirikizumab, and Janssen’s Tremfya (guselkumab); and Takeda’s subcutaneous formulation of Entyvio (vedolizumab) in the US.”

InDex Pharmaceuticals’ cobitolimod is an agent with both a novel MOA and a new route of administration, as the TLR9 agonist is administered locally to the large intestine via rectal enema. Obefazimod, developed by Abivax, is a micro-RNA-124 upregulator, another novel MOA for this indication. Based on positive results, Abivax is currently planning global Phase III trials for obefazimod, which are expected to begin in September 2022.

Towler notes: “There are currently three companies developing IL-23 inhibitors for moderate-to-severe UC patients: AbbVie’s Skyrizi, Eli Lilly’s mirikizumab, and Janssen’s Tremfya. While all three agents are currently undergoing Phase III trials, GlobalData expects Eli Lilly’s mirikizumab to be the first IL-23-specific inhibitor to be approved for this indication. In May 2022, Eli Lilly announced interim data from its Phase III LUCENT-2 trial, which demonstrated strong efficacy for their product. GlobalData expects regulatory approval of mirikizumab for UC in Q1 2023 in the US and Q2 2023 in the EU.”

Takeda is also continuing to work with the FDA on US approval of the subcutaneous (SC) formulation of its anti-αβ integrin monoclonal antibody, Entyvio. While already approved in other major markets, GlobalData anticipates regulatory approval of Entyvio SC in the US in Q2 2023. The approval of this agent will strengthen Takeda’s portfolio and provide an easier route of administration for patients utilizing Entyvio for UC management.

Towler concludes: “While there are many agents available for the treatment of UC, GlobalData believes novel pipeline agents such as cobitolimod, obefazimod, the IL-23 inhibitors, and Entyvio SC in the US will prove to be useful and effective additions to the treatment space. One of the more promising agents in the pipeline is Eli Lilly’s mirikizumab, the company’s first agent for UC. Becoming the first approved IL-23 inhibitor for this indication will help establish Eli Lilly as a key player in the UC market going forward.”