Genovese discusses recent data that shows Omvoh’s effectiveness at treating IBD.
Pharmaceutical Executive: Can you provide a breakdown on the data presented at DDW 2025?
Mark Genovese, MD: At DDW this year, Lilly highlighted data from multiple studies that show Omvoh® (mirikizumab-mrkz) improved the patient experience with meaningful relief from disruptive symptoms and reduced complications for people living with inflammatory bowel disease (IBD):
We presented 12-week data from the LUCENT-URGE study in patients with ulcerative colitis (UC), showing Omvoh significantly reduced bowel urgency and improved stool deferral time, which is the amount of time a person can delay going to the bathroom. Omvoh is the first treatment to show improvements in stool deferral time for people with UC.
A new, one-year analysis from the LUCENT trials also showed Omvoh reduced hospitalizations and surgeries in people with UC, which can reduce patient burden.
In addition, we shared two-year, long-term data from the VIVID-2 trial, originally presented at the Crohn’s and Colitis Congress, which found the vast majority of patients with moderately to severely active Crohn’s disease who achieved clinical remission and endoscopic response at one year sustained it with two years of continuous treatment.
PE: How do these data underscore Lilly’s commitment to improving the patient experience?
Genovese: The long-term Crohn’s disease data for Omvoh show how Lilly is setting a high bar for delivering long-term treatment with sustained response for patients. Patients with these conditions often do not achieve clinical remission with treatment, and of those who do, a substantial proportion lose it within the first year.
In addition, our Omvoh data in UC demonstrate how Lilly is assessing innovative treatment measures that can better evaluate the impact on a patient’s life, extending beyond clinical remission to include bowel urgency, endo-histologic endpoints, and sustained remission.
Our commitment to improving the patient experience also goes beyond data, including a citrate-free formulation of Omvoh now available for subcutaneous maintenance treatment, which aims to reduce injection-related pain for patients and has the same active ingredient without a citrate buffer. Lilly is also reducing cost barriers to ensure patients have access to our treatments, including a patient support program offering co-pay assistance for eligible, commercially insured patients.
PE: What are your future plans for Omvoh?
Genovese: We are advancing research for Omvoh across a range of patient populations. In UC, we expect to share four-year efficacy and safety data building on the three-year data we announced last year. Omvoh is also being studied in Phase 3 trials for pediatric patients in UC and in a Phase 2 trial in combination with eltrekibart for patients with moderately to severely active UC. Additionally, we recently posted two clinical trials on clinicaltrials.gov looking at Omvoh in combination with tirzepatide in IBD.
PE: What are the trends in treatments in the gastroenterology space?
Genovese: First, we are making big bets on next-generation modalities and the expansion of our small-molecule pipeline, including oral medicines. Oral therapies are of particular interest, as they could open new possibilities for earlier intervention and provide the potential for combination therapy to help patients with more severe disease. One example of this is our acquisition of Morphic and the potential for MORF-057 in IBD, currently being studied in the EMERALD-2 and GARNET trials.
Additionally, we believe incretins have the potential for significant health benefits, including in immune system conditions like IBD. Our distinct and diverse R&D portfolio uniquely positions us to lead in this area, and we have initiated research that can potentially support better health outcomes for people with IBD and obesity or overweight with at least one weight-related comorbid condition. This is currently being studied in the COMMIT-UC and COMMIT-CD trials with concomitantly administered mirikizumab and tirzepatide.
