Mirikizumab helps patients with UC achieve clinical remission
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Lilly announced mirikizumab for treatment of ulcerative colitis met primary and secondary endpoints in the LUCENT-1 12-week, phase 3 induction study, according to a press release.
LUCENT-1 assessed the efficacy and safety of mirikizumab for treatment of patients with moderate-to-severe UC.
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"There is a continued need for additional treatments that can provide people living with ulcerative colitis relief from their most challenging symptoms," William J. Sandborn, MD, professor of medicine, and chief, division of gastroenterology, University of California, San Diego, said in the release. "Results of this study provide further clinical evidence of the potential for mirikizumab to become the first anti-IL-23p19 biologic for the treatment of ulcerative colitis."
In a comparison between mirikizumab and placebo, mirikizumab met the primary endpoint of clinical remission at 12 weeks (P < .0001) per the release. Additionally, patients who received mirikizumab vs. placebo achieved secondary endpoints at 12 weeks with statistically significant p-values, including reduced bowel urgency, clinical response, endoscopic remission, symptomatic remission and improvement in endoscopic histologic inflammation.
Mirikizumab reportedly decreased symptoms in patients who originally did not respond to treatment or stopped responding to biologic and/or Janus kinase inhibitor therapies.
"People living with UC often struggle to effectively manage recurring flare ups of the disease," Lotus Mallbris, MD, PhD, vice president of immunology development at Lilly, said in the release. "With these positive results, we look forward to the continuation of the maintenance study through 52 weeks in hopes of providing a new option to people living with UC."
Investigators are now conducting LUCENT-2, an ongoing, randomized, double-blind, placebo-controlled maintenance study of mirikizumab in patients who completed the LUCENT-1 induction study.
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