Lilly's Omvoh Outperforms J&J's Stelara in Phase III Crohn’s Disease Trial

Eli Lilly has presented promising long-term data from its Phase III VIVID-1 study, showing that its monoclonal antibody Omvoh achieved a superior histologic response at one year compared to Johnson & Johnson’s (J&J) Stelara in treating patients with Crohn’s disease. This study provides hope for improved long-term outcomes for patients suffering from this chronic inflammatory condition.

After 52 weeks of follow-up, a higher percentage of patients treated with Omvoh demonstrated a histologic response, as per the European Crohn’s and Colitis Organization’s (ECCO) criteria on mucosal histopathology. This positive outcome was observed not only in the overall study population but also in a specific subgroup of patients who had active histologic disease at the start and had failed at least one prior biologic treatment. Eli Lilly stated that these results were statistically significant.

The safety profile of Omvoh in VIVID-1 was consistent with its known safety information, with adverse events including anemia, joint pain, and upper respiratory tract infections. Interestingly, serious adverse events were more common in the placebo group, adding to the credibility of Omvoh's safety.

Mark Genovese, senior vice president of development at Lilly Immunology, highlighted the significance of these findings, suggesting that the company is raising the standards for evaluating long-term treatment responses in inflammatory bowel disease, with a focus on achieving ambitious targets of mucosal healing.

Omvoh is a humanized IgG4 monoclonal antibody that selectively targets and inhibits the IL-23 cytokine, which in turn prevents its interaction with its receptor. This mechanism helps modulate the differentiation, proliferation, and survival of various T cells and innate immune cells, leading to a reduction in mucosal inflammation.

Approved for the treatment of moderately to severely active ulcerative colitis since October 2023, Omvoh is the latest addition to Lilly’s portfolio. The company is now using the VIVID-1 data to seek regulatory approval for expanding Omvoh's label to include Crohn’s disease, aiming to gain acceptance from the FDA and other global health authorities.

Furthermore, Lilly is committed to exploring the full therapeutic potential of Omvoh in inflammatory bowel diseases through ongoing clinical trials in both Crohn’s disease and ulcerative colitis in pediatric populations.

Should Lilly succeed in getting Omvoh approved for Crohn’s disease, it will provide strong competition to J&J’s Stelara, a well-established treatment in the realm of inflammatory diseases. Stelara has been a major revenue driver for J&J, with sales surging by 11.7% to nearly $10.9 billion in 2023. However, Stelara faces mounting challenges due to the expiration of its key patents and the rise of biosimilar competitors.

In April 2024, Teva and Alvotech received FDA approval for Selarsdi, a biosimilar to Stelara for treating psoriatic arthritis and plaque psoriasis. Despite this, Selarsdi has not been approved for Crohn’s disease and ulcerative colitis. Additionally, in July 2024, Samsung Bioepis obtained regulatory approval for its biosimilar Pyzchiva, which will compete with Stelara across psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

The introduction of Omvoh and the entry of new biosimilars could significantly alter the competitive landscape for treatments of inflammatory bowel diseases, potentially offering patients more effective and varied therapeutic options in the near future.