Eli Lilly and Co. said its bowel disease drug mirikizumab helped patients reach significantly greater rates of clinical remission, compared to placebo, in a phase 2 trial.
The study enrolled patients with moderate-to-severe ulcerative colitis who previously failed conventional or biologic therapy. Patients received either mirikizumab in doses ranging from 50 milligrams to 600 milligrams, or placebo.
After 12 weeks of treatment, between 11.5% and 22.6% of patients in the mirikizumab groups achieved clinical remission, compared to 4.8% in the placebo group.
For the secondary trial goals, between 41.3% and 59.7% of patients showed a clinical response to mirikizumab, compared to 20.6% for placebo. Between 13.1% and 30.6% of patients in the mirikizumab groups achieved endoscopic healing, compared to 6.3% in the placebo group.
The incidence of adverse events was similar across patient groups.
Ulcerative colitis, or UC, is a disease of the colon that causes long-lasting inflammation and ulcers in the digestive tract. The disease affects millions of people worldwide, and there is an unmet need for therapies that can relieve symptoms and provide sustained remission, the Indianapolis-based pharmaceutical giant said.
The company is developing mirikizumab as a treatment for various immune diseases and plans to proceed with phase 3 program in UC.
