Eli Lilly’s anti-IL-23p19 monoclonal antibody (mAb) mirikizumab has met the primary endpoint and all key secondary endpoints in a Phase III ulcerative colitis (UC) study.
The 12-week LUCENT-1 induction study evaluated mirikizumab for the treatment of patients with moderate to severe UC.
UC is a chronic and often debilitating inflammatory disease of the large intestine that affects millions of people globally.
Symptoms of UC can include chronic diarrhoea with blood and mucus, abdominal pain and cramping, and weight loss. UC can have a significant effect on work, family and social activities.
In LUCENT-1, mirikizumab hit the primary endpoint of clinical remission at week 12 compared to placebo. This means that inflammation of the colon is controlled or resolved, leading to normalisation or near-normalisation of symptoms.
In addition, mirikizumab met all key secondary endpoints in patients with UC at week 12, with ‘highly statistically significant’ p-values.
This included reduced bowel urgency, clinical response, endoscopic remission, symptomatic remission and improvement in endoscopic histologic inflammation.
Mirikizumab also demonstrated rapid improvement in patient symptoms as early as four weeks after initiating treatment, and reduced symptoms among patients who had previously not responded or had stopped responding to biologic or Janus kinase (JAK) inhibitor therapies.
"People living with UC often struggle to effectively manage recurring flare ups of the disease," said Lotus Mallbris, vice president of immunology development at Lilly.
"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,” she added.