In an oral presentation from the Digestive Disease Week medical conference in San Diego, California today, Eli Lilly and Company (NYSE: LLY) announced new safety and efficacy data for mirikizumab in patients with moderately- to severely active Crohn’s disease.
INDIANAPOLIS, May 21, 2019 /PRNewswire/ -- In an oral presentation from the Digestive Disease Week medical conference in San Diego, California today, Eli Lilly and Company (NYSE: LLY) announced new safety and efficacy data for mirikizumab in patients with moderately- to severely active Crohn’s disease. Patients treated with mirikizumab in the SERENITY Phase 2 study achieved significant reductions in clinical and endoscopic measures of disease activity at 12 weeks compared to placebo. The maintenance phase of this study is ongoing. In this study, patients with moderately- to severely active Crohn’s disease were randomized to receive either placebo or one of three doses of mirikizumab, which is an investigational antibody that targets the p19 subunit of interleukin 23. The primary endpoint evaluated mirikizumab versus placebo on endoscopic response, which was defined as a 50 percent reduction from baseline in the severity of each patient’s disease, as measured by the Simple Endoscopic Score for Crohn’s Disease (SES-CD)1. Secondary endpoints included clinical remission as measured by Patient Reported Outcomes (PRO remission), endoscopic remission, and safety. At 12 weeks, treatment with mirikizumab achieved the following results:
Bruce E. Sands, MD, MS, Dr. Burrill B. Crohn Professor of Medicine, Chief of the Dr. Henry D. Janowitz Division of Gastroenterology at the Icahn School of Medicine at Mount Sinai and lead investigator of the study, said “Mirikizimab may have the potential to be a valuable addition to the available treatment options for Crohn’s disease because of the endoscopic and symptomatic responses seen in this trial across all doses.” Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly, said “Following last year’s presentation of positive Phase 2 results for mirikizumab for the treatment of moderate- to severe ulcerative colitis, we are excited to return to DDW to present more positive data for mirikizumab in patients with chronic, inflammatory gastrointestinal conditions. As we continue to advance the science of gastroenterology, we are hopeful that mirikizumab helps us raise the standard and make remission possible for people living with immune-mediated diseases like Crohn’s disease. Physicians want objective signs of improvement to be able to convey to patients that they are getting better, and data from this study suggest mirikizumab may address this need. We look forward to initiating Phase 3 trials to further evaluate mirikizumab’s benefit-risk profile for the treatment of Crohn’s disease.” About Mirikizumab About Crohn’s Disease About the Mirikizumab Phase 2 Trial in Crohn’s Disease About Lilly in Immunology About Eli Lilly and Company This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about mirikizumab as a potential treatment for moderately- to severely active Crohn’s disease and moderate- to severe ulcerative colitis, and reflects Lilly’s current belief. As with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date, that mirikizumab will receive additional regulatory approvals, or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly’s most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertake no duty to update forward-looking statements to reflect events after the date of this release. 1 “The Simple Endoscopic Score for Crohn’s Disease (SES-CD) assesses the size of mucosal ulcers, the [area of the] ulcerated surface, the endoscopic extension and the presence of stenosis,” which in Crohn’s disease is the pathological narrowing of the gastrointestinal tract. http://www.igibdscores.it/en/info-sescd.html Accessed, May 17, 2019. Refer to: View original content to download multimedia:http://www.prnewswire.com/news-releases/lillys-mirikizumab-met-primary-endpoint-and-key-secondary-endpoints-in-phase-2-study-including-reductions-of-gastrointestinal-lesions-300854236.html SOURCE Eli Lilly & Company | ||
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