Eli Lilly’s Omvoh and Johnson & Johnson’s Tremfya have demonstrated impressive remission and response rates in patients afflicted with Crohn’s disease, as showcased in recent Phase III trial results presented at the prestigious 2024 American College of Gastroenterology Annual Scientific Meeting, which took place from October 25 to 30 in Philadelphia.
On Monday, J&J unveiled compelling findings from the Phase III GRAVITI study, revealing that 56.1% of patients administered a subcutaneous formulation of Tremfya achieved clinical remission after just 12 weeks. In stark contrast, only 21.4% of patients in the placebo group experienced similar results. Furthermore, the endoscopic remission rate in the Tremfya cohort at this benchmark was an encouraging 41.3%, compared to 21.4% for those receiving the placebo treatment.
As the trials progressed to the 48-week mark, the clinical remission rate elevated to an impressive 60% for patients on a 100-mg maintenance dose of subcutaneous Tremfya, administered every eight weeks. Notably, those receiving a 200 mg maintenance dose every four weeks achieved an even higher clinical remission rate of 66.1%. In contrast, only 17.1% of placebo participants attained clinical remission at this evaluation point.
Esi Lamousé-Smith, the gastroenterology disease area lead at J&J Innovative Medicines, stated that these results indicate Tremfya’s “potential to become the sole IL-23 inhibitor to offer both SC and IV induction options for Crohn’s disease.” If granted approval to expand its application in this field, Tremfya will provide patients with a more convenient self-administration option from the beginning of their treatment regimens, according to Lamousé-Smith.
A recent report published by GlobalData underscored Tremfya’s potential to establish a “new standard” in the management of Crohn’s disease, given its “patient-friendly” administration profile. GlobalData immunology analyst Sumaira Malik emphasized that Tremfya’s “positive clinical profile, coupled with its unique dual-binding mechanism, positions it as a differentiated option within its class.” She hailed the subcutaneous regimen as a “significant step forward for patients” who require effective treatment options. Projections suggest Tremfya’s global sales could reach an impressive $7.8 billion by 2029.
In addition to J&J’s advancements, Lilly also reported promising long-term data for Omvoh on the same day. The company revealed that the anti-IL23p19 antibody achieved a remarkable 96% clinical response rate in patients, assessed by the Crohn’s Disease Activity Index. Long-term data further indicated that 87% of patients reached clinical remission, 76% exhibited an endoscopic response, and 54% were in endoscopic remission.
Mark Genovese, Lilly’s senior vice president of immunology development, highlighted 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,” showcasing the innovative nature of this treatment.
Both pharmaceutical giants, Lilly and J&J, are actively pursuing the expansion of their respective therapies into the Crohn’s disease market after receiving approvals for ulcerative colitis treatments. J&J submitted its supplemental Biologics License Application for Tremfya in June 2024, bolstered by Phase III data from the GALAXI program, which demonstrated that Tremfya produced significantly improved endoscopic outcomes compared to the widely used drug Stelara.
Lilly made it known in May 2024 that it had filed for a supplemental application for Omvoh’s expansion. Earlier this month, the pharmaceutical company also revealed favorable results from the late-stage VIVID-1 trial, which illustrated that Omvoh surpassed Stelara regarding histologic response.
