Eli Lilly and Johnson & Johnson presented Phase III data at the 2024 American College of Gastroenterology Annual Scientific Meeting, showcasing the potential of their respective drugs, Omvoh (Lilly) and Tremfya (J&J), in treating Crohn's disease. Both companies are vying to expand their drugs' indications following approvals for ulcerative colitis.
Johnson & Johnson's Tremfya Shows Strong Remission Rates
J&J's Phase III GRAVITI study revealed that 56.1% of patients treated with a subcutaneous formulation of Tremfya achieved clinical remission at 12 weeks, significantly higher than the 21.4% in the placebo group. The endoscopic remission rate at the same time point was 41.3% for Tremfya versus 21.4% for placebo.
At 48 weeks, the clinical remission rate increased to 60% for patients on a 100-mg maintenance dose of subcutaneous Tremfya every eight weeks, and to 66.1% with a 200-mg dose every four weeks. In contrast, the placebo group showed only a 17.1% clinical remission rate.
Esi Lamousé-Smith from J&J Innovative Medicines highlighted Tremfya's potential to be the only IL-23 inhibitor offering both subcutaneous and IV induction options for Crohn’s disease, providing patients with a more convenient self-administration option from the start of treatment.
GlobalData analysts suggest Tremfya could set a new standard in Crohn's disease treatment due to its patient-friendly administration and predict global sales to reach $7.8 billion by 2029. Sumaira Malik, an immunology analyst at GlobalData, noted the drug's unique dual-binding mechanism as a differentiator.
Lilly's Omvoh Demonstrates Long-Term Efficacy
Lilly presented long-term data for Omvoh, indicating a 96% clinical response rate in Crohn's disease patients, as measured by the Crohn’s Disease Activity Index. The long-term results also showed that 87% of patients reached clinical remission, 76% showed endoscopic response, and 54% were in endoscopic remission.
Follow-up data for Omvoh in moderate to severely active ulcerative colitis showed an 81% long-term clinical remission rate and an 82% long-term endoscopic remission rate. Additionally, 72% and 79% of patients achieved mucosal healing and corticosteroid-free clinical remission, respectively.
Mark Genovese, Lilly’s senior vice president of immunology development, emphasized that Omvoh is the first and only IL23p19 antagonist to report multi-year, long-term sustained efficacy data in both ulcerative colitis and Crohn’s disease.
Market Positioning and Regulatory Pathways
J&J submitted its supplemental Biologics License Application for Tremfya in June 2024, following Phase III data from the GALAXI program, which demonstrated significantly better endoscopic outcomes than Stelara. Lilly announced its filing for Omvoh’s expansion in May 2024 and recently released data from the VIVID-1 trial, showing Omvoh outperformed Stelara in terms of histologic response.
