Lilly’s mirikizumab met primary endpoint and key secondary endpoints in Phase 2 study, including reductions of gastrointestinal lesions
The safety and efficacy data from the induction period of the Phase 2 trial encourage Lilly to initiate a Phase 3 trial for mirikizumab for the treatment of Crohn’s disease later this year
TORONTO, ON – May 22, 2019 - In an oral presentation from the Digestive Disease Week (DDW) medical conference in San Diego, California today, Eli Lilly and Company announced new safety and efficacy data for mirikizumab in patients with moderately- to severely active Crohn’s disease. Patients treated with mirikizumab in the SERENITY Phase 2 study achieved significant reductions in clinical and endoscopic measures of disease activity at 12 weeks compared to placebo. The maintenance phase of this study is ongoing.
In this study, patients with moderately- to severely active Crohn’s disease were randomized to receive either placebo or one of three doses of mirikizumab, which is an investigational antibody that targets the p19 subunit of interleukin 23. The primary endpoint evaluated mirikizumab versus placebo on endoscopic response, which was defined as a 50 per cent reduction from baseline in the severity of each patient’s disease, as measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD). Secondary endpoints included clinical remission as measured by Patient Reported Outcomes (PRO remission), endoscopic remission, and safety.
At 12 weeks, treatment with mirikizumab achieved the following results:
Endoscopic response: Rates of endoscopic response, which was defined as a 50 per cent reduction from baseline in the severity of each patient’s disease, as measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD), were significantly greater for all mirikizumab doses compared to placebo: 25.8 per cent, 37.5 per cent, and 43.8 per cent of patients in the 200 mg, 600 mg, and 1000 mg groups, respectively, achieved response compared to 10.9 per cent of placebo patients.
Endoscopic remission: Endoscopic remission, which was defined as an ileal-colonic SES-CD score of less than 4, an isolated ileal SES-CD score of less than 2, and no subscore greater than 1, was achieved in 6.5 per cent, 15.6 per cent and 20.3 per cent of patients treated with mirikizumab 200 mg, 600 mg and 1000 mg respectively, versus 1.6 per cent of patients treated with placebo.
PRO remission: PRO remission, which was defined as an average daily stool frequency of less than or equal to 2.5, and abdominal pain less than or equal to 1, was achieved in 12.9 per cent, 28.1 per cent and 21.9 per cent of patients treated with mirikizumab 200 mg, 600 mg and 1000 mg, respectively, compared to 6.3 per cent of patients treated with placebo.
Safety assessment: Across the 3 mirikizumab treatment groups, 5 patients (4 per cent) reported one or more serious adverse event (SAE), and 81 patients (64 per cent) reported one or more treatment emergent adverse event (TEAE) during the induction phase of the trial. The most commonly reported TEAEs were headache, weight gain, and nasopharyngitis. Among the placebo group, 7 patients (11 per cent) reported one or more SAE, and 45 patients (70 per cent) reported one or more TEAE.
“We are pleased to add to the already positive Phase 2 results for mirikizumab for the treatment of moderate-to-severe ulcerative colitis presented at DDW last year, and show promising new data in patients with chronic, inflammatory gastrointestinal conditions,” says Doron Sagman, Vice President, Medical Affairs, Lilly Canada. “Immunology is a major focus at Lilly and as we advance science in areas like gastroenterology, we are hopeful that mirikizumab will be a new treatment option for people living with immune-mediated diseases like Crohn’s disease.”
“Strong Phase 2 data with positive clinical and endoscopic outcomes show that mirikizumab could be a new option that can provide symptom relief for patients with immune diseases,” says Dr. Vipul Jairath, Associate Professor of Medicine and the John and Susan Macdonald Chair in Inflammatory Bowel Disease at Western University and London Health Sciences Centre, London, Ontario.
Mirikizumab is an investigational 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. The safety and efficacy are still under investigation and mirikizumab has not received marketing authorization.
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, effects 270,000 Canadians. i
About the Mirikizumab Phase 2 Trial in Crohn's Disease
The Phase 2, multi-centre, 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 measured endoscopic response as determined by the proportion of participants achieving 50 per cent reduction from baseline on the Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12. Secondary endpoints included clinical remission as measured by Patient Reported Outcomes (PRO remission), endoscopic remission, and safety.
About Lilly in Immunology
Lilly is bringing our heritage of championing groundbreaking, novel science to immunology and is driven to change what's possible for people living with autoimmune diseases. There are still significant unmet needs, as well as personal and societal costs, for people living with a variety of autoimmune diseases and our goal is to minimize the burden of disease. Lilly is investing in leading-edge clinical approaches across our immunology portfolio in hopes of transforming the autoimmune disease treatment experience. We've built a deep pipeline and are focused on advancing cutting edge science to find new treatments that offer meaningful improvements to support the people and the communities we serve.
About Lilly Canada
Eli Lilly and Company is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by Colonel Eli Lilly, who was committed to creating high quality medicines that meet people’s needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to people who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism.
Eli Lilly Canada was established in 1938, the result of a research collaboration with scientists at the University of Toronto which eventually produced the world’s first commercially-available insulin. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at www.lilly.ca.
i. Crohn’s & Colitis Canada (Impact of IBD in Canada Report - Crohn’s and Colitis Canada)