Strong 52-week Mirikizumab Phase II data holds promise for Eli Lilly in Crohn’s disease

New data unveiled at the United European Gastroenterology Week (UEGW) virtual conference showed that Eli Lilly’s Crohn’s disease (CD) hopeful, mirikizumab, can deliver durable endoscopic and symptomatic efficacy after 52 weeks in moderate-to-severe patients who had failed or were intolerant to conventional therapy and had failed at least one other biologic agent. mirikizumab’s prospects are favorable in the competitive CD market. Although it will have to contend with many drugs in late-stage development, data and analytics company GlobalData expects mirikizumab to generate 2029 sales of $155m in the eight major markets.

Antoine Grey, Senior Immunology Analyst at GlobalData, comments: “The latest longer-term efficacy results from the SERENITY study were backed up by data detailing the durability of efficacy endpoints at Week 52. Results showed that both IV and SC mirikizumab were similarly durable in terms of endoscopic response and PRO remission, but SC mirikizumab was marginally more impressive when it came to endoscopic remission and CDAI remission. These data present a strong case for mirikizumab’s place in the treatment paradigm of CD, as well as instilling confidence in the novel mechanism of action.”

Despite the promise demonstrated by mirikizumab, it will be entering a very competitive CD market that will see three other anti-IL-23 biologics vying for best in class by 2029. GlobalData expects AbbVie’s Skyrizi (risankizumab) will be first in class for CD, after seeing good uptake in psoriasis.

Grey notes: “mirikizumab will have to contend with Janssen’s Tremfya (guselkumab) and AstraZeneca’s brazikumab. However, the promise of efficacy and safety that IL-23 biologics such as mirikizumab have shown may help gastroenterologists choose them instead of Stelara (ustekinumab), the currently marketed anti-IL-12/23 biologic. While more research is needed, it is suspected that targeting IL-23 alone, instead of IL-12 and IL-23 together, may result in greater efficacy and safety.

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