Eli Lilly and Co. (NYSE:LLY) unveiled new data on Tuesday from LUCENT-3, the single-arm long-term Phase 3 open-label extension of LUCENT-1 and LUCENT-2, which evaluated the efficacy and safety of mirikizumab in patients with ulcerative colitis for an additional three years of treatment (up to four years total).
The data showed that Omvoh (mirikizumab-mrkz) is the first and only interleukin-23p19 (IL-23p19) inhibitor to help patients with moderately to severely active ulcerative colitis achieve sustained, long-term outcomes for up to four years.
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The results were seen across multiple symptomatic, clinical, endoscopic, histologic, and quality-of-life measures, including among patients who had previously failed a biologic or advanced therapy (27%).
In LUCENT-3, the following results were observed after four years of total treatment among those who achieved clinical remission with Omvoh at one year in the Phase 3 LUCENT-2 study:
78% achieved corticosteroid-free clinical remission
78% sustained long-term clinical remission.
81% sustained endoscopic remission, defined as an endoscopic subscore of 0 or 1 (excluding friability).
90% achieved remission on the Inflammatory Bowel Disease Questionnaire (IBDQ).
66% achieved histological-endoscopic mucosal improvement, an important marker of deep inflammation resolution.
93% achieved a three or more-point reduction on the Urgency Numeric Rating Scale (UNRS), and 74% achieved UNRS = 0 or 11.
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.
Of patients who completed one year of blinded Omvoh maintenance therapy in LUCENT-2 and continued to LUCENT-3, 12% reported a serious adverse event, while 7% discontinued treatment due to an adverse event.
In February, Eli Lilly shared the results from the VIVID-2 open-label extension study of Omvoh in Crohn’s disease patients.
Price Action: LLY stock is currently trading at $845.46, as of the last check on Tuesday.
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