On a mission to collect a key Crohn’s disease approval and build out its inflammatory bowel disease (IBD) profile, Eli Lilly has notched a trial win over a major rival in a head-to-head study.
When stacked up against Johnson & Johnson’s Stelara, Eli Lilly's Omvoh prompted histologic responses in more patients with moderately to severely active Crohn's disease, regardless of biologic treatment history, by week 52, Lilly reported on Monday.
The same result was achieved among patients with active histologic disease at baseline and with at least one prior biologic treatment failure, according to Lilly. In that patient population, Omvoh prompted more responses on the combined histologic-endoscopic measure over the same time frame.
For the histologic response measure, investigators closely assess patients' tissue samples to look for inflammation and levels of disease activity. To measure endoscopic responses, doctors look at patients' disease activity through an endoscope.
The study, dubbed VIVID-1, is the first phase 3 trial for a Crohn’s disease candidate to report histologic and combined histologic-endoscopic outcomes using a systemic assessment of five bowel segments and definitions that match up with the European Crohn's and Colitis’ recent position statement on mucosal histopathology, according to Lilly.
Omvoh, an IL-23 inhibitor, picked up its first FDA approval last year as an ulcerative colitis (UC) treatment following a manufacturing-related delay. Now, the company is chasing a nod for the other type of IBD, Crohn’s, and has filed approval bids across the globe.
The drug's new win over Stelara comes after a phase 3 study reported last year showed it couldn't demonstrate superiority over Johnson & Johnson's immunology blockbuster in the endoscopic response measure. Still, Lilly said the Omvoh results were "numerically higher" than for Stelara.
Besides Stelara, other competitors in the IBD space include AbbVie’s Skyrizi and Rinvoq. While Omvoh has yet to take flight in the Crohn’s disease space, Skyrizi has already bested its market share in UC despite Lilly’s first-to-market advantage.
According to a recent Spherix Global Insights poll, Skyrizi took the title of the dominant drug in the UC market just two months after its approval, with most surveyed gastroenterologists already having prescribed by the time they were questioned. AbbVie’s dominance was attributed to the company’s long history in IBD, while Lilly is newer to the game.
Meanwhile, another market shakeup could come next year from a wave of Stelara biosimilars, while J&J's newer Tremfya has recently gained its own UC nod.