Lilly unveils mirikizumab data in ulcerative colitis as it preps filings

Eli Lilly has reported phase 3 results with its ulcerative colitis challenger mirikizumab, as it waits for the readout of a second trial in the coming weeks that will allow it to file for regulatory approvals.

The new data comes from the 1,162-subject LUCENT-1 trial – first unveiled last year – which compared induction treatment with the anti-IL-23p19 antibody to placebo in patients with moderately-to-severely active ulcerative colitis who had not tried a biologic therapy before.

The study found that 24% of patients treated with mirikizumab were in clinical remission at 12 weeks – meaning inflammation of the colon is controlled or resolved – compared to 13% of the placebo group

Symptoms such as stool frequency, bowel urgency and bleeding were abolished in 46% of the mirikizumab group and 28% of the control group, and 22% of those taking Lilly’s antibody saw an impact on symptoms within four weeks of starting the drug.

Now, all eyes are on the outcome of the LUCENT-2 trial, which is looking at the role of mirikizumab in the post-induction maintenance setting.

Those results were teased in December, with Lilly reporting that significantly more patients treated with maintenance dosing were in clinical remission at one year compared to placebo. The actual numbers are due to be presented in the first half of this year and will be followed by regulatory filings, according to the drugmaker.

Mirikizumab was once tipped by analysts as a potential blockbuster, but expectations for the drug took a tumble last year when Lilly decided to end its development in psoriasis, saying the market had become too crowded.

The challenge facing Lilly is that ulcerative colitis already has some heavyweight biologic competition from the likes of Johnson & Johnson with IL-23 inhibitor Stelara (ustekinumab) and AbbVie with TNF inhibitor Humira (adalimumab), along with lower-cost, biosimilar versions of the latter drug.

AbbVie’s IL-23 inhibitor Skyrizi (risankizumab) has meanwhile already been filed for approval in ulcerative colitis, and J&J has just reported positive phase 2b data with anti-IL-23p19 antibody Tremfya (guselkumab) as a first-line induction therapy for the disease as well as for second-line treatment of patients who have not responded to other drugs.

Also emerging onto the scene are oral therapies including Bristol-Myers Squibb’s already-approved S1P therapy Zeposia (ozanimod) – with Arena Pharma’s etrasimod following closely after in phase 3 – as well as JAK inhibitors like AbbVie’s Rinvoq (upadacitinib) and BMS’ TYK2 inhibitor deucravacitinib.

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