Lilly reveals promising data in ulcerative colitis as it prepares for regulator filings

Pharma News: Results from Eli Lilly’s first-in-class induction study in moderate-to-severe active ulcerative colitis (UC) was presented last week at the 17th Congress of the European Crohn’s and Colitis Organisation (ECCO).

In the LUCENT-1 Phase 3 study, patients who took mirikizumab achieved statistically superior rates of clinical remission at 12 weeks compared to patients taking placebo.

“People with ulcerative colitis have mucosal inflammation in the colon, which causes rectal bleeding, frequent trips to the bathroom and the urgent need to have a bowel movement,” said Dr Geert D’Haens, lead author and Professor of Gastroenterology at Amsterdam University Medical Centres.

“Mirikizumab has the potential to significantly reduce inflammation, help people achieve remission and reduce bowel urgency, which is a novel, patient-centric outcome that hasn’t been studied before in a Phase 3 trial for ulcerative colitis.”

The global UC induction study of 1,162 patients included biologic-naïve and harder-to-treat patients who had previously failed on a biologic. One in four patients treated with mirikizumab (24.2%) achieved the primary endpoint of clinical remission at 12 weeks, compared to one in seven on placebo (13.3%, p=0.00006).

Mirikizumab is also the first anti-IL23p19 to demonstrate maintenance of clinical remission at one year in the LUCENT-2 Phase 3 study in UC, with all key secondary endpoints met.

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The challenge facing Lilly is the busy UC market including the biologic competition from Janssen’s IL-23 inhibitor Stelara (ustekinumab) and AbbVie’s TNF inhibitor Humira (adalimumab), alongside biosimilars.

Other therapies with future UC approvals include AbbVie’s IL-23 inhibitor Skyrizi (risankizumab), which is currently under TGA review for the treatment of Crohn’s disease, and Janssen’s anti-IL-23p19 antibody Tremfya (guselkumab), currently indicated in plaque psoriasis and psoriatic arthritis.

Also emerging are oral therapies including Bristol-Myers Squibb’s (BMS) S1P therapy Zeposia (ozanimod) and JAK inhibitors like AbbVie’s Stelara (ustekinumab) and BMS’ TYK2 inhibitor deucravacitinib.

The full results from Lilly’s LUCENT induction and maintenance studies are anticipated in early 2022. Data from an open label extension study for eligible patients who have participated in mirikizumab UC trials will also become available.

Lilly plans to submit applications to regulators in the first half of 2022.