Lilly has announced that its interleukin-23 blocker mirikizumab demonstrated promise in patients with moderately to severely active ulcerative colitis (UC) in the ongoing open-label LUCENT-3 extension study. The trial evaluated two-year efficacy and safety of the monoclonal antibody in patients who had previously undergone UC treatments, including biologics, that were ineffective, stopped working, or were intolerable.
In April, the company announced that it had received a complete response letter for mirikizumab for UC as a result of issues FDA identified related to the proposed manufacturing of the antibody. The agency noted no concerns about the clinical data package, safety, or label for the therapy.
After revealing the most recent LUCENT-3 data, Lilly plans on filing a marketing application for mirikizumab in Crohn’s disease to FDA. It intends to file paperwork with other regulatory agencies in 2024.
Mirikizumab efficacy in LUCENT-3
The LUCENT-3 study highlighted mirikizumab’s potential as a long-term therapy in UC. For those who responded to treatment at week 52, 74.5% demonstrated sustained clinical response at week 104. In addition, remission rates at this same point for week 52 clinical responders were also significant, with 54.0% achieving clinical remission, 52.7% achieving corticosteroid-free (CSF) remission, and 65.3% reaching endoscopic remission.
For patients deemed to be week-52 clinical remitters, the results were even more encouraging. A total of 76.6% showed a clinical response at week 104, with remission rates including 65.6% for clinical, 64.3% for CSF, and 77.3% for endoscopic remission.
The treatment was generally well-tolerated yet clinical trial investigators noted severe treatment-emergent adverse events (TEAEs) in 4.5% of patients, and 5.2% experienced serious AEs. The most common TEAEs were COVID-19 (12.1%) and ulcerative colitis (7.6%). No deaths were reported.
In related news, Johnson & Johnson shared data from its interleukin-23 blocker guselkumab (Tremfya), which showed continued promise in Crohn’s disease (CD) in a long-term extension portion of a phase 2 study. First winning FDA approval for plaque psoriasis in 2017, guselkumab recently demonstrated robust efficacy and a consistent safety profile in the long-term extension of the GALAXI Phase 2 study for CD
Filed Under: clinical trials, Drug Discovery, Gastroenterology