Eli Lilly’s mirikizumab triumphs in Phase 3 Crohn’s disease study
Eli Lilly and Company (NYSE: LLY), a pharmaceutical leader, unveiled that mirikizumab, its cutting-edge interleukin-23p19 antagonist, has demonstrated its prowess against placebo in the critical VIVID-1 Phase 3 trial. The study, crucial for those with moderately to severely active Crohn’s disease, has established mirikizumab as a beacon of hope in the treatment landscape.
Striking Results for mirikizumab in VIVID-1 Clinical Trial
Crohn’s disease, an inflammatory bowel disease causing distressing symptoms and potential complications, is at the center of the VIVID-1 double-blind, treat-through trial. Mirikizumab showcased a stellar performance:
– Clinical Response at Week 12: An impressive 45.4% in the mirikizumab arm compared to a mere 19.6% with placebo.
– Endoscopic Response at Week 52: Mirikizumab outperformed the placebo with 38.0% compared to the latter’s 9.0%.
Moreover, mirikizumab achieved all major secondary endpoints, further reinforcing its potential as an efficacious treatment for Crohn’s disease.
Lilly prepares for FDA submission after encouraging mirikizumab clinical results. Photo courtesy of Momoneymoproblemz/Wikimedia Commons.
Industry Insights
Dr. Lotus Mallbris, a senior figure at Lilly, expressed enthusiasm about the game-changing outcomes. Emphasizing the drug’s efficacy, especially in patients where other biologic therapies failed, Mallbris spotlighted Lilly’s commitment to innovating in the inflammatory bowel diseases domain.
Mirikizumab Safety Profile
Mirikizumab’s safety is in line with its known profile. Interestingly, the frequency of serious events was higher in the placebo than mirikizumab. Common adverse events included COVID-19, anemia, and headaches, among others. Crucially, no major adverse cardiac events were noted in the mirikizumab treatment group.
Towards Global Recognition
Harnessing these promising results, Eli Lilly is gearing up to present mirikizumab to the FDA in 2024, targeting Crohn’s disease treatment. Subsequent submissions to global regulatory bodies are also on the horizon. Current indications for mirikizumab encompass treatment for ulcerative colitis in nations like Japan, Germany, and the UK.