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July 12, 2021updated 12 Jul 2022 11:06am

Lilly’s mirikizumab induces gene expression changes in Phase II UC trial

Changes in gene transcript with mirikizumab were linked to mucosal healing, indicating its effect on a molecular healing pathway.

Eli Lilly has reported the latest data from the Phase II trial in which mirikizumab stimulated gene expression changes in ulcerative colitis (UC) patients over a 12-week induction treatment and maintained them for up to one year.

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A humanised IgG4 monoclonal antibody, mirikizumab attaches to the p19 subunit of interleukin 23. It is being developed to treat immune diseases.

The latest results showed that the gene transcript changes observed in the mirikizumab arm were linked to mucosal healing, showing that the drug acts on a unique molecular healing pathway compared with the quick healing noted in the placebo arm.

According to data from the previously published Phase II study, mirikizumab demonstrated down-regulation of multiple gene transcripts linked to inflamed mucosa.

The drug also up-regulated gene transcripts associated with healthy mucosa and markers of functional healing in UC subjects after 12 weeks.

The latest analysis found that nearly 71% of the modulated genes were observed in subjects with a response to mirikizumab as against 5.6% in those responding to placebo.

These findings at 12 weeks were consistent for up to one year in mirikizumab-treated participants.

Furthermore, the safety profile of mirikizumab at 52 weeks was in line with other UC trials and with the class.

Another analysis in patients with moderate to severe UC assessed mirikizumab’s role in the meaningful improvement of bowel urgency, a UC symptom linked to increased levels of disease activity.

In this study, 50% of the subjects noted that a one-point improvement on the urgency numeric rating scale (NRS) would be a meaningful change.

Nearly 25% of subjects reported a two-point change and another 25% indicated a three-point change or more in the urgency NRS was required for significant improvements in the quality of life.

In addition, of the 75% of subjects who validated a one to two-point change, initial scores on the urgency NRS varied from two to nine, demonstrating that this amount of change was meaningful irrespective of a patient’s bowel urgency severity.

Eli Lilly Immunology global development leader Prentice Stovall Jr said: “Given the impact that bowel urgency has on an individual’s ability to work and overall quality of life, this analysis will help us further understand the experience of people with UC and the potential impact of our treatments on this burdensome and debilitating symptom.”

Apart from UC, mirikizumab is currently being analysed for treating Crohn’s disease, an inflammatory bowel disease.

Last month, Lilly reported posthoc analyses data from the Phase III RA-BEAM study that showed Olumiant 4mg reduced pain and duration of morning joint stiffness in moderate to severe rheumatoid arthritis patients.

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As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
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