Eli Lilly’s Omvoh (mirikizumab-mrkz) has shown four-year disease-clearance in patients with moderately to severely active ulcerative colitis (UC).
In the LUCENT-3 (NCT03519945) open-label extension study, 63.5% of Omvoh-treated patients who achieved disease clearance at one year sustained it at four years. Even in those requiring endoscopic normalisation in addition to symptomatic and histologic remission, 61.3% who achieved clearance at one year maintained it through four years.
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Disease clearance is the simultaneous achievement of symptomatic, endoscopic and histologic remission.
Lilly says that this study represents the first time an interleukin-23p19 (IL-23p19) inhibitor has demonstrated durable disease clearance through four years in people with UC.
Dr Jean-Frédéric Colombel, director of the Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center at the Icahn School of Medicine at Mount Sinai, said: “What makes these data so compelling is that they go beyond individual measures of improvement to show that patients treated with Omvoh achieved disease clearance, with simultaneous symptomatic, endoscopic and histologic remission, maintained over four years. Until now, disease clearance has not been demonstrated for this length of time for any IL-23p19 therapy in UC. That level of durable remission has the potential to change the long-term course of the disease for patients.”
The long-term safety profile in patients with moderately to severely active UC was consistent with the known safety profile of Omvoh, with no new safety signals observed.
This builds on the previous four-year Omvoh data, which showed that 78% achieved corticosteroid-free clinical remission and 78% sustained long-term clinical remission.
Lilly received approval of Omvoh from the US Food and Drug Administration (FDA) in UC in October 2023 based on the LUCENT programme. Omvoh has also been approved in moderately to severely active Crohn’s disease.
Data from LUCENT-3 will be presented at Digestive Disease Week(DDW), taking place from 2-5 May in Chicago.
This data builds on three-year results in Crohn‘s disease, including a reduction of serious disease-related complications.
Lilly is also investigating new candidates in UC, including studies with eltrekibart (NCT06598943), a monoclonal antibody that targets neutrophil-driven inflammation, and with zotemtegrast (NCT07186101), an oral α4β7 integrin inhibitor.
GlobalData predicts that the UC market will rise from $11.1bn in 2021 to $14.7bn in 2031 across the 68 markets, with $9.6bn of that predicted to come from the eight major markets (8MM: US, France, Germany, Italy, Spain, UK, Japan, and Canada).
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