By Daniel Ojeda, Ph.D.
On October 12th, Eli Lilly and Company presented their SERENITY Phase 2 clinical trial results for Mirikizumab in patients with moderately to severely active Crohn’s disease. The results show that nearly 60% of patients had a reduction in inflammation of the bowel lining, and just under 50% reduction in self-reported abdominal pain and daily stool frequency.
Mirikizumab is a humanized monoclonal antibody that targets interleukin 23, a protein that is involved in inflammation. Mirikizumab is being studied to treat immune diseases, including psoriasis, ulcerative colitis, and Crohn’s disease. Mirikizumab will not the first monoclonal antibody targeting interleukin 23 in the market if approved by the FDA. It will have to compete with Johnson and Johnson’s drug Ustekinumab, sold under brand name STELARA.
Besides Crohn’s disease, Mirikizumab is being studied for the treatment of psoriasis and ulcerative colitis. In July, Lilly announced that Mirikizumab met all primary endpoints against placebo and secondary endpoints against Novartis’ Cosentyx in the OASIS-2, Phase 3 study.
Crohn’s disease is an inflammatory bowel disease characterized by mild to severe diarrhea, abdominal pain, fever, weight loss, and others. More than 10 million people are affected worldwide, and the exact causes of this disease remain unknown. Two of the factors shown to play a role in the development of Crohn’s disease are an overactive immune system, this is when the immune system attacks the cells in your digestive tract and heredity.
There are multiple treatments approved to treat Crohn’s disease; however, because most of the drugs interfere with the body’s immune response, they can lead to severe side effects. New treatments with fewer side effects are necessary for this disease. Some of the treatments include small molecule immune system suppressor drugs such as Azathioprine and Methotrexate; however, these can lead to serious side effects and require regular checkups. Additionally, several antibody therapies targeting parts of the inflammatory response have been approved to treat Crohn’s disease. These treatments also increase the risk of severe infections, and Natalizumab treatment carries a small risk of developing multifocal leukoencephalopathy.
During the United European Gastroenterology Week (UEG Week) 2020, Eli Lilly presented the results for their multi-center, randomized, parallel-arm, double-blind, placebo-controlled Phase 2 clinical trial SERENITY (LY3074828). The trial had two phases, first, a 12-week phase, in which patients were separated into four groups, three received Mirikizumab and one placebo. After this period, people showing reduced inflammation as measured using the Simple Endoscopic Score for Crohn’s Disease (SEC-CD) continued Mirikizumab either intravenously or subcutaneously for 40 weeks. The patients with no improvement on SEC-CD or that received placebo were assigned to receive the treatment intravenously.
At the end of the 52 weeks, almost 60% of the patients showed a reduction in inflammation measured by endoscopy of at least 50%. Additionally, more than 45% of the patients reported a reduction in abdominal pain and average daily stool. The most common side effects were nasopharyngitis, headache, and joint pain. These are promising results and highlight the importance of the ongoing Phase 3 clinical trial.
“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. “With these encouraging Phase 2 results, we look forward to continuing our clinical program for Mirikizumab with the hope that we can provide help for those living with Crohn’s disease.”
Editor: Rajaneesh K. Gopinath, Ph.D.
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