Eli Lilly and Company is expected to apply for a Biologics License Application in the first half of 2022.
New phase 3 data shows mirikizumab has resulted in clinical remission for patients with moderately-to-severely active ulcerative colitis.
Eli Lilly and Company announced the results at the 1 year mark from the LUCENT-2 trial, testing the efficacy and safety of the drug.
Each patient enrolled in the phase 3 maintenance study was previously enrolled in LUCENT-1, a 12-week induction study.
In the maintenance trial, the investigators enrolled patients who achieved clinical response with mirikizumab and re-randomized to mirikizumab maintenance dosing or placebo. The investigators found a statistically higher proportion of patients met the primary endpoint of clinical remission at 1 year compared to the placebo group (P <0.001).
Clinical remission was defined as when inflammation when the colon in controlled or resolved, which leads to the normalization or near-normalization of symptoms like frequent or bloody stools.
Along with meeting the primary endpoints of the trial, the investigators also met all key secondary endpoint (P <0.001), including significantly higher proportions of patients treated with the study drug achieving endoscopic remission, corticosteroid-free remission, resolution, or near-resolution of bowel urgency, improvement in endoscopic histologic intestinal inflammation, and maintenance of remission and greater reduction from baseline in bowel urgency symptoms at 1 year compared to placebo.
"In this maintenance study, treatment with mirikizumab demonstrated clinically meaningful and statistically significant improvements in clinical, endoscopic and histologic measures, including reduction of bowel urgency – a novel endpoint in the LUCENT program," said Bruce E. Sands, MD, MS, Dr. Burrill B. Crohn Professor of Medicine, Chief of the Dr. Henry D. Janowitz Division of Gastroenterology at the Icahn School of Medicine at Mount Sinai, in a statement.
"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."
For safety, the investigators found the frequency of serious adverse events in the mirikizumab group was numerically lower than the serious adverse events in the placebo group, with a safety profile consistent with what was previous found in mirikizumab studies for ulcerative colitis and other trials within the anti-IL-23p19 antibody class.
The most common treatment emergent adverse events in the mirikizumab group was nasopharyngitis, arthralgia, and the exacerbation of ulcerative colitis, as well as various adverse events of interest including hypersensitivity, injection site reaction, depression, liver enzyme elevation, herpes zoster, and oral candidiasis.
Eli Lilly and Company is expected to submit a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) in the first half of 2022.
"The results announced today are encouraging for those who live with ulcerative colitis," said Michael Osso, President and CEO for Crohn's & Colitis Foundation, in a statement. "We're excited about potential new options in the inflammatory bowel disease treatment space that may be able to help people living with ulcerative colitis successfully control their disease symptoms and achieve remission."