Mirikizumab Shows Continued Symptom Improvement and Reduction of Intestinal Inflammation in Patients with Crohn's Disease in 52-Week Phase 2 Trial
In the induction period, patients were randomized across four treatment arms to receive placebo or one of three doses of mirikizumab intravenously. At 12 weeks, patients who showed endoscopic improvement were randomized to continue mirikizumab treatment, administered either intravenously or subcutaneously. Patients who did not show endoscopic improvement or who had been randomized to the placebo arm in induction were assigned to receive mirikizumab treatment intravenously.
In the continued treatment period of the study, patients achieved key secondary outcomes at Week 52 including endoscopic response (defined as at least 50% reduction from baseline in Simple Endoscopic Score for Crohn's Disease [SES-CD]), PRO remission (defined as an average daily stool frequency of ≤2.5 and abdominal pain ≤1 and no worse than baseline) and endoscopic remission (defined as achieving an SES-CD score <4 for ileal-colonic disease or <2 for isolated ileal disease, and no subscore >1).
- Endoscopic response: Nearly 60% of patients achieved endoscopic response (58.5% in the randomized IV dosing group and 58.7% in the SC group).
- PRO remission: More than 45% of patients achieved PRO remission (46.3% in the IV group and 45.6% in the SC group).
"Crohn's disease is a serious and difficult-to-treat condition, and there is a significant need for additional treatments. I am encouraged by the results of this study, which showed response in both symptom relief and endoscopic response and remission at 52 weeks of treatment with mirikizumab," said
Among the subset of patients who achieved endoscopic response at Week 12, 69.6% and 66.7% in the IV (n=23) and SC (n=24) groups, respectively, also had endoscopic response at Week 52. Additionally, among those with endoscopic remission at Week 12, 50.0% and 64.3% in the IV (n=6) and SC (n=14) groups, respectively, also had endoscopic remission at Week 52.
"People who live with moderate to severe Crohn's disease need additional treatment options and are looking for innovative therapies that can address their challenging and painful symptoms," said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at
One patient in each group among those who showed endoscopic improvement at Week 12 discontinued due to an adverse event (AE). Similar frequencies of treatment-emergent AEs and serious AEs were reported in IV and SC groups. The most common treatment-emergent AEs reported were nasopharyngitis (4.9% in IV group, 13% in SC group), headache (7.3% in IV group, 8.7% in SC group) and arthralgia (joint pain) (7.3% in IV group, 13% in SC group).
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Mirikizumab is a humanized IgG4 monoclonal antibody that binds to the P19 subunit of interleukin 23. Mirikizumab is being studied for the treatment of immune diseases, including psoriasis, ulcerative colitis and Crohn's disease.
About Crohn's Disease
Crohn's disease, which is a form of inflammatory bowel disease (IBD), is a chronic immune-mediated condition of the gastrointestinal (GI) tract. Crohn's most commonly affects the end of the small bowel (the ileum) and the beginning of the colon, but it may affect any part of the GI tract, from the mouth to the anus. IBD, which is inclusive of Crohn's disease and ulcerative colitis, affects 10 million people worldwide.
About the Mirikizumab Phase 2 Trial in Crohn's Disease
SERENITY, the Phase 2, multi-center, randomized, parallel-arm, double-blind, placebo-controlled trial was designed to assess the safety and efficacy of mirikizumab in patients with moderately to severely active Crohn's disease. At baseline, participants were randomized with a 2:1:1:2 allocation across four treatment arms (mirikizumab 200 mg, mirikizumab 600 mg, mirikizumab 1000 mg, and placebo). The primary endpoint was endoscopic response as determined by the proportion of participants achieving at least 50 percent reduction from baseline on the Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12. In
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about mirikizumab as a potential treatment for moderate-to-severe plaque psoriasis, Crohn's disease and ulcerative colitis, and reflects
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