Lilly's Omvoh Outperforms J&J's Stelara in Phase 3 Crohn’s Disease Trial, Offering New Hope for Patients

On October 14, 2024, local time, Eli Lilly announced the positive results of the phase 3 clinical trial VIVID-1 for the IL-23 antibody mirikizumab (Omvoh) in treating patients with moderate to severe Crohn's disease, showing a better histological response over one year in Crohn's disease patients compared to Johnson & Johnson's Stelara.

Image Source: Eli Lilly Official Website

The VIVID-1 study is a randomized, double-blind, Phase 3 clinical trial. In the VIVID-1 study, compared with placebo, mirikizumab achieved statistically significant improvements in all histological and histological-endoscopic endpoints at Week 12 and Week 52.

At Week 52, a greater proportion of patients in the mirikizumab group achieved histologic response in the overall population (58.2% vs 48.8%; p=0.0075). In patients with active histologic disease at baseline and at least one prior biological failure, mirikizumab also demonstrated a higher histologic response at Week 52 (56.5% vs 41.3%; p=0.0064) and endoscopic response at Week 52 (39.6% vs 27.8%; p=0.024).

In terms of mechanism of action, mirikizumab, as a humanized IgG4 monoclonal antibody, selectively targets and inhibits the IL-23 cytokine, preventing its interaction with the receptor, thereby modulating T cells and innate immune cells to effectively suppress mucosal inflammation.

In terms of safety, its adverse events are consistent with the known characteristics in ulcerative colitis. Common side effects include anemia, arthralgia, and upper respiratory tract infections, and the incidence of severe adverse events was higher in the placebo group.

Reviewing the journey of mirikizumab, it received U.S. FDA approval in October 2023 for the treatment of adult patients with moderate to severe active ulcerative colitis. The LUCENT clinical trial data disclosed by Eli Lilly at the time showed that mirikizumab induced high clinical response and remission rates after 12 weeks of treatment, with effects lasting up to one year. It is important to note that its approved label includes precautions such as an increased risk of infections, hypersensitivity reactions, and hepatotoxicity.

Lilly is actively using the data from the VIVID-1 study to submit regulatory applications to the FDA and other global health authorities to expand the label for mirikizumab. Currently, Lilly is also conducting trials for pediatric Crohn's disease and ulcerative colitis, continuously exploring its therapeutic potential.

Johnson & Johnson's Stelara achieved nearly $10.9 billion in sales in 2023 with an 11.7% growth rate, showing strong market performance. However, mirikizumab has now emerged as a potential competitor. Additionally, due to the expiration of key patent protections, Stelara also faces competition from biosimilars. In 2024, several biosimilars have been approved for the treatment of certain diseases, but none yet for Crohn’s disease and ulcerative colitis. Whether Eli Lilly's mirikizumab can successfully establish itself in the Crohn’s disease treatment market and expand its reach remains to be seen.