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Eli Lilly's IL-23p19 inhibitor mirikizumab in the treatment of ulcerative colitis (UC) phase 3 clinical study was successful!

 Last Update: 2021-04-28
 Source: Internet
 Author: User

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News on March 18, 2021 /bioon.
com" target="_blank">/ - bioon.
com/tags/%E7%A4%BC%E6%9D%A5/">Eli Lilly (Eli Lilly) recently announced that the new anti-inflammatory drugs mirikizumab assess the treatment of moderate to severe ulcerative colitis (UC) in three LUCENT-1 study (NCT03518086) reached the primary endpoint and key secondary endpoints of all.
This is a 12-week induction phase 3 study conducted in patients with moderate to severe UC who have failed conventional and/or biological therapies to evaluate the efficacy and safety of mirikizumab.
Currently, another multi-center, randomized, double-blind, placebo-controlled maintenance study LUCENT-2 (NCT03524092) is underway.
This study enrolls patients who have completed the 12-week treatment of the LUCENT-1 induction study.

bioon.
com" target="_blank">bioon.
com/tags/%E7%A4%BC%E6%9D%A5/">Eli Lilly

mirikizumab is a humanized IgG4 monoclonal antibody that targets the p19 subunit of IL-23.
The drug is currently being developed for a variety of immune diseases, including plaque psoriasis (PsO) and ulcerative colon Inflammation (UC) and Crohn's disease (CD), etc.
The phase 3 clinical project LUCENT of mirikizumab for the treatment of UC includes 3 studies, namely LUCENT-1, LUCENT-2, and LUCENT-3 (NCT03519945).
The last study was carried out in patients who have participated in the bioon.
com/course_video/lin-chuang-shi-yan-de-feng-xian-jian-kong239833.
html">clinical trial of mirikizumab for the treatment of UC .
The project was launched in 2018, and the complete results of the induction study and maintenance study are expected to be obtained in early 2022.

bioon.
com/course_video/lin-chuang-shi-yan-de-feng-xian-jian-kong239833.
html">Clinical Trials

UC is a chronic inflammatory disease of the large intestine (also known as the colon).
It affects the lining of the colon and may lead to the formation of small sores or ulcers.
This inflammation can cause abdominal pain, frequent and urgent toilet trips, bloody stools and urinary incontinence.
UC can cause severe and debilitating interruptions in daily life.
Globally, millions of people suffer from UC.

William J.
Sandborn, MD, director of the Department of Gastroenterology and Professor of Medicine at the University of California, San Diego, said: “Additional treatments are still needed to free ulcerative colitis (UC) patients from the most challenging symptoms.
This The results of the study provide further clinical evidence that mirikizumab has the potential to become the first anti-IL-23p19 biologic for the treatment of ulcerative colitis.
"

mirikizumab has the potential to become the first anti-IL-23p19 biologic for the treatment of ulcerative colitis.

UC (Image source: healthjade.
com)

In the LUCENT-1 study, compared with placebo, mirikizumab reached the primary endpoint of clinical remission at week 12 (p<0.
0001).
When the inflammation of the colon is controlled or relieved, and the symptoms such as stool frequency and bleeding are normalized or nearly normalized, clinical remission can be achieved.
Compared with placebo, mirikizumab also reached all key secondary endpoints at week 12, with a highly statistically significant p-value, including bowel urgency, clinical response, endoscopic relief, symptom relief, and improvement of endoscopic tissue inflammation .
In addition, mirikizumab showed rapid improvement in patients' symptoms 4 weeks after starting treatment.
Mirikizumab can also reduce symptoms in patients who have previously failed or stopped responding to biological and/or Janus kinase (JAK) inhibitor therapy.

In the 12-week placebo-controlled induction study LUCENT-1, the incidence of adverse events (TEAE) and serious adverse events (SAE) during treatment in mirikizumab-treated patients was the same as the previous phase 2 study of mirikizumab in the treatment of UC And anti-IL-23p19 antibody research is consistent.
The most common bioon.
com/course_info/series_11.
html">adverse reactions in the placebo group and mirikizumab group included nasopharyngitis, bioon.
com/tags/%E8%B4%AB%E8%A1%80/">anemia, and headache.

bioon.
com/course_info/series_11.
html">Adverse Reaction bioon.
com/tags/%E8%B4%AB%E8%A1%80/">Anemia

bioon.
com/tags/%E7%A4%BC%E6%9D%A5/">Lilly is responsible for bioon.
com/course_info/series_7.
html">immunology Lotus Mallbris Ph.
D.
, vice president of medical development expressed: "UC patients are often difficult to effectively control recurrent disease With these positive results, we look forward to continuing to promote the maintenance study until 52 weeks, hoping for the UC patients.
Provide a new option.
" ()

bioon.
com/tags/%E7%A4%BC%E6%9D%A5/">Eli Lilly bioon.
com/course_info/series_7.
html">Immunology ()

Original source: Lilly's Mirikizumab Helps Patients Achieve Clinical Remission and Improves Symptoms in Adults with Ulcerative Colitis in 12-Week Phase 3 Induction Study

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