Eli Lilly's Mirikizumab Shows Long-Term Sustained Efficacy, Safety For Ulcerative Colitis And Crohn's Disease

On Monday, Eli Lilly And Co LLY announced results from two Phase 3 studies of mirikizumab across two types of inflammatory bowel diseases (IBD).

The studies showed patients treated with mirikizumab sustained stable, long-term remission in ulcerative colitis and Crohn’s disease.

Data from the two trials – LUCENT-3 in moderately to severely active ulcerative colitis and VIVID-2 in moderately to severely active Crohn’s disease – will be presented at the American College of Gastroenterology Annual Meeting.

Mirikizumab is approved as Omvoh in the U.S. for moderately to severely active ulcerative colitis in adults and is under FDA review for moderately to severely active Crohn’s disease.

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In the LUCENT-3 trial, mirikizumab helped patients with moderately to severely active ulcerative colitis achieve long-term outcomes, including histologic-endoscopic mucosal remission, defined as mucosal healing.

Mirikizumab also provided sustained benefit across symptomatic, clinical, endoscopic, and histologic endpoints for up to three years, regardless of previous failure to TNF inhibitors, tofacitinib, or other biologics. 

• 81% of patients maintained long-term clinical remission.
• 82% achieved long-term endoscopic remission.
• 72% had mucosal healing.
• 79% achieved corticosteroid-free clinical remission.
• Patients demonstrated a sustained clinically meaningful improvement in symptom score reduction for bowel urgency (-4.72).
• Among patients receiving mirikizumab in the LUCENT-3 study, 7.4% reported a serious adverse event (AE), while 5.3% discontinued treatment due to an AE.

New data from patients in the Phase 2 program who enrolled in the VIVID-2 long-term extension study showed that patients with moderately to severely active Crohn’s disease treated with mirikizumab maintained high clinical and endoscopic remission rates.

• 96% of patients had clinical response as measured by the Crohn’s Disease Activity Index (CDAI).
• 87% were in clinical remission as measured by CDAI.
• 76% had endoscopic response.
• 54% of patients were in endoscopic remission.

Eli Lilly submitted marketing applications for mirikizumab for Crohn’s disease around the globe, including in the U.S., Canada, Europe, Japan, and China.

Additionally, Eli Lilly has a combination study in ulcerative colitis with mirikizumab and eltrekibart.

There are also ongoing studies for ulcerative colitis and Crohn’s disease with MORF-057.

Price Action: LLY stock is up 0.33% at $895.61 at last check Monday.

Photo by Jonathan Weiss via Shutterstock

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