INDIANAPOLIS - Eli Lilly and Company (NYSE:LLY) announced successful results from the Phase 3 VIVID-1 study of mirikizumab, a treatment for Crohn's disease, a chronic inflammatory bowel condition. The study found that mirikizumab led to significant improvements in clinical and endoscopic endpoints over one year compared to a placebo.
Patients with moderately to severely active Crohn's disease, including those who had not responded to previous biologic treatments, were part of the trial. According to the findings, 54.1% of patients achieved clinical remission, and 48.4% achieved an endoscopic response after 52 weeks of treatment with mirikizumab.
The study also compared mirikizumab to ustekinumab, another therapy for Crohn's disease. Mirikizumab showed nominally statistically significant higher rates of combined clinical remission and endoscopic response, particularly among patients with previous biologic failure. However, mirikizumab did not achieve superiority to ustekinumab for endoscopic response alone.
Safety profiles for mirikizumab in the trial were consistent with previous findings in ulcerative colitis patients, with serious adverse events being more common in the placebo group. The most common adverse events included COVID-19, anemia, arthralgia, headache, upper respiratory tract infection, nasopharyngitis, and injection site reaction.
Eli Lilly has submitted a supplemental Biologics License Application for mirikizumab in Crohn's disease to the U.S. Food and Drug Administration and the European Medicines Agency, with additional global regulatory submissions planned.
These results were presented at Digestive Disease Week, held in Washington, D.C., and are based on a press release statement from Eli Lilly and Company.
InvestingPro Insights
As Eli Lilly and Company (NYSE:LLY) showcases promising results for mirikizumab, a Crohn's disease treatment, investors may be interested in the financial health and market performance of the company. Eli Lilly has demonstrated a strong commitment to its shareholders, as evidenced by its history of dividend payments. The company has not only maintained dividend payments for 54 consecutive years but has also raised its dividend for 9 consecutive years, showcasing its financial stability and dedication to returning value to shareholders.
InvestingPro data highlights the company's robust financial performance, with a significant revenue growth of 29.76% over the last twelve months as of Q1 2024. The company's gross profit margin stands at an impressive 80.16%, indicating efficient operations and cost management. Additionally, Eli Lilly has achieved a high return over the past year, with a 1 Year Price Total Return of 78.36%, reflecting investor confidence and market recognition of the company's growth prospects.
An InvestingPro Tip points out that Eli Lilly is trading at a high earnings multiple, with a P/E Ratio of 114.97, suggesting high investor expectations for future earnings growth. While some analysts have revised their earnings expectations downwards for the upcoming period, the company's strong track record and the potential of new treatments like mirikizumab could provide a positive outlook for long-term investors.
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