03 Nov Crohn’s Disease: Lilly’s Mirikizumab Has Potential to Achieve Remission in Phase 3 Study

MedicalResearch.com Interview with:

Dr. Mallbris

Lotus Mallbris, M.D., Ph.D.,
Senior Vice President of Immunology Development
Eli Lilly

MedicalResearch.com: Would you briefly describe the condition of Crohn’s disease and who is most susceptible to this disease?

Response: Crohn’s disease is a form of inflammatory bowel disease (IBD) that can cause systemic inflammation manifested as abdominal pain, diarrhea, fever and weight loss. It can lead to intestinal obstruction, fibrosis and other complications.

Approximately 900,000 patients in the U.S. and 1 million patients in Europe are currently suffering from Crohn’s disease, and 70% of those have moderate to severe disease. Although the majority of patients are started on conventional therapy such as corticosteroids and immunomodulators, many will unfortunately progress to having moderate to severe disease.

Furthermore, current therapies to treat Crohn’s disease often fail to achieve remission for a majority of patients, and of the patients who do achieve remission, a substantial proportion lose it within the first year.

MedicalResearch.com:  How does mirikizumab differ from other treatments for Crohn’s disease?

Response:  Mirikizumab is an investigational medicine and currently not approved for the treatment of moderately to severely active Crohn’s disease. While we cannot make direct comparisons between the clinical effects of mirikizumab and other medicines that we have not conducted head-to-head studies against, we know that many people are seeking relief from their uncontrolled Crohn’s disease, including those still experiencing symptoms despite available therapies such as TNF inhibitors.

Mirikizumab works by selectively targeting the p19 subunit of IL-23, which plays a role in inflammation related to inflammatory bowel diseases.

In the VIVID-1 study, Lilly included Stelara® (ustekinumab), an IL-12/23 antagonist, as an active comparator to provide healthcare providers and patients with comparative data between mirikizumab and a currently available treatment option for Crohn’s disease. This double-blind placebo and active controlled trial was the first reported for an IL-23p19 antibody.

MedicalResearch.com: What are the main findings?

Response: In the Phase 3 study, mirikizumab met the co-primary endpoints, which included the proportion of participants achieving clinical response by patient reported outcomes (PRO) at Week 12 and clinical remission (defined as a Crohn’s Disease Activity Index [CDAI] Total Score <150) at Week 52 compared to placebo, as well as the proportion of participants achieving clinical response by PRO at Week 12 and endoscopic response (defined as ≥50% reduction from baseline in Simple Endoscopic Score – Crohn’s Disease [SES-CD] Total Score) at Week 52 compared to placebo.

Additionally, mirikizumab achieved all individual and composite major secondary endpoints at Week 52 compared to placebo (p<0.000001). Notably, of the patients who received mirikizumab, 54.1% achieved clinical remission at Week 52 compared to 19.6% of patients who received placebo (p<0.000001).

For the endpoint of clinical remission (defined as CDAI <150), mirikizumab demonstrated non-inferiority versus ustekinumab (non-inferiority margin of 10%). Although the results for mirikizumab in endoscopic response (≥50% reduction from baseline in SES-CD Total Score) at Week 52 were numerically higher, particularly in the non-multiplicity controlled bio-failed population, it did not reach superiority versus ustekinumab.

These results with mirikizumab are exciting for people living with moderately to severely active Crohn’s disease. Data like these further inspire us to develop potential innovative treatments for inflammatory bowel diseases, including Crohn’s disease, to help patients achieve long-term clinical remission. 

MedicalResearch.com: What are the next steps in development?

Response: With these data, Lilly plans to submit a marketing application for mirikizumab in Crohn’s disease to the Food and Drug Administration (FDA), followed by submissions to other regulatory agencies around the world, in 2024.

MedicalResearch.com: Is there anything else you would like to add?

Response: We are pleased with the results of the VIVID-1 study, which demonstrated that mirikizumab has the potential to help people with Crohn’s disease achieve clinical remission. We are currently analyzing the VIVID data, and additional results from the VIVID-1 study will be presented at future scientific conferences and/or submitted for publication in a peer reviewed journal.

Citation:

1: Mirikizumab: First Approval
Keam SJ. Mirikizumab: First Approval. Drugs. 2023 Jul;83(11):1045-1052. doi: 10.1007/s40265-023-01909-1. PMID: 37389706.

https://link.springer.com/article/10.1007/s40265-023-01909-1

2: Lilly’s Mirikizumab Shows Long-Term Remission in Phase III Crohn’s Trial

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Last Updated on November 3, 2023 by Marie Benz