- Eli Lilly's experimental antibody mirikizumab led to higher rates of clinical response and remission in patients with ulcerative colitis treated in a mid-stage study, which the pharma touted as the first public presentation of data from a IL-23p19 monoclonal antibody in the inflammatory condition.
- Data announced Tuesday showed between 12% and 23% of patients treated with mirikizumab achieved clinical remission compared to only 4.8% given placebo, although only the 200 mg dose-adjusted arm reached statistical significance.
- Lilly plans to begin a Phase 3 study of the drug in moderate-to-severe ulcerative colitis later in 2018. The drug is also in development for other immune diseases, including psoriasis and Crohn's disease.
A variety of treatments are available for ulcerative colitis, a debilitating inflammatory bowel disease (IBD), but few lead to sustained clinical remission. In 2015, around 1.3% of the U.S. adult population were diagnosed with IBD, up from 0.9% in 1999, according to the Centers for Disease Control and Prevention. Ulcerative colitis, along with Crohn's, are two of the most common types of IBD.
Current treatment includes drugs like the TNF inhibitors Humira (adalimumab) and Remicade (infliximab). But there a number of experimental compounds aiming to join the market.
Experimental approaches include sphingosine-1-phosphate receptor-1 (S1P1) agonists like Celgene's ozanimod and JAK inhibitors like AbbVie's upadacitinib.
Lilly's IL-23p19 monoclonal antibody could be another tool in the treatment arsenal if it clears further testing and reaches markets.
All doses of the drug met statistical significance compared to placebo on clinical response, but treatment groups besides the 200 mg dose-adjusted cohort did not yield a significant difference versus control.
The proportion of patients who experienced endoscopic healing was also not statistically significant.
The results may change over time, according to William Sandborn, chief of the division of gastroenterology at the University of California San Diego School of Medicine.
"I am particularly encouraged by the symptomatic response and remission data we've seen thus far, and look forward to having data from later periods in the study to provide insight about the degree to which endoscopy results continue to improve over time, as we've observed in other clinical programs for UC," he said, in a Lilly release.