Eli Lilly and Company (NYSE:LLY) announced that its interleukin-23 subunit p19 inhibitor mirikizumab achieved its primary endpoint of clinical remission at 52 weeks in the Phase 3 LUCENT-2 study.
Lilly says mirikizumab is the first anti-IL23p19 to demonstrate maintenance of clinical remission in a Phase 3 ulcerative colitis study.
Janssen (NYSE:JNJ) has ongoing clinical trials testing its interleukin-23 subunit p19 inhibitor guselkumab (Tremfya) as an inflammatory bowel disease therapy. Studies are ongoing testing guselkumab for adults with moderately to severely active ulcerative colitis.
Participants in Lilly’s LUCENT-2 study were previously enrolled in a 12-week induction study known as LUCENT-1.
Subjects in LUCENT-2 were rerandomized to receive mirikizumab maintenance dosing.
Lilly notes that a statistically higher number of mirikizumab recipients achieved clinical remission at one year than placebo recipients.
“Bowel urgency is one of the most bothersome and disruptive symptoms people living with ulcerative colitis experience, and the LUCENT program leveraged an innovative and systematic patient-centric approach to assess patients’ symptoms,” said Bruce E. Sands, of the Icahn School of Medicine at Mount Sinai, in a statement.