A new treatment has landed in Korea for moderate to severe active ulcerative colitis that has not responded adequately to standard treatments or biologics or has become unresponsive.

Lilly Korea said Thursday that the interleukin-23 (IL-23) inhibitor Omvoh (mirikizumab) has received approval from the Ministry of Food and Drug Safety (MFDS) for treating ulcerative colitis.

Omvoh selectively targets the p19 subunit of IL-23, which plays a role in the inflammation associated with ulcerative colitis. Currently, Omvoh is the only treatment utilizing this mechanism of action.

OMVO can normalize cytokine production by selectively blocking IL-23, a regulatory cytokine that affects the differentiation, expansion, and survival of T-cell subsets and innate immune cell subsets, the source of the pro-inflammatory cytokines (including IL-17A, IL-17F, and IL-22), which cause inflammatory diseases.

With the MFDS approval, Omvoh can be used to treat moderate to severe active ulcerative colitis in adults (18 and older) who have not responded adequately to, lost response to, or are intolerant of conventional therapies (such as corticosteroids or immunosuppressive agents) or biologics.

After 12 weeks of induction therapy (300 mg intravenous infusion at weeks 0, 4, and 8), patients may be switched to maintenance therapy (200 mg subcutaneous injection every four weeks) if assessments show sufficient response to treatment. If sufficient therapeutic benefit isn't observed at Week 12, extended induction therapy may continue through Weeks 12, 16, and 20, followed by maintenance therapy if additional intravenous infusions prove beneficial.

Omvoh's approval is based on data from two randomized, double-blind, multicenter phase 3 clinical trials in patients with moderate to severe ulcerative colitis, defined as a modified Mayo score of 4-9, including an endoscopic subscore of ≥ 2 of the disease activity score (Mayo score), diagnosed for at least three months.

Patients are those who had a prior failure (loss of response, inadequate response, or intolerance) to corticosteroids or immunomodulatory agents (6-mercaptopurine, azathioprine) or one or more biologics (TNF-α inhibitors and/or vedolizumab) or tofacitinib. LUCENT-1 was an intravenous induction trial for up to 12 weeks, followed by a subcutaneous randomized discontinuation maintenance trial (LUCENT-2) for 40 weeks.

The LUCENT-1 induction trial evaluated the efficacy of 1,162 randomized patients 3:1 to receive intravenous Omvoh 300 mg or placebo at weeks 0, 4, and 8.

In LUCENT-1, more than one in four patients (24.2 percent) in the Omvoh-treated group achieved clinical remission at week 12, significantly higher than the placebo group (13.3 percent). This clinical efficacy was consistent across subgroups.

Patients in the Omvoh treatment arm also experienced greater reductions in the rectal bleeding subscore and bowel frequency subscore compared to placebo starting at week 2. In LUCENT-1, 63.5 percent of patients in the Omvoh treatment arm achieved a clinical response, compared to 42.2 percent in the placebo arm.

In LUCENT-2, nearly half (49.9 percent) of patients treated with Omvoh achieved clinical remission during the maintenance period (40 weeks), significantly higher than the placebo arm (25.1 percent).

Of those patients who achieved clinical remission in LUCENT-1, 63.6 percent of those treated with Omvoh in LUCENT-2 maintained clinical remission, compared to 36.9 percent in the placebo arm.

"Ulcerative colitis is a chronic disease with a complex etiology that includes genetic, immunologic, infectious, and psychosocial factors, and despite treatment, ulcerative colitis has a chronic course with repeated remissions and flare-ups," Llly Korea CEO Christopher J. Stokes said.

There is a need for a treatment option that can provide rapid and sustained symptomatic improvement, especially for patients whose symptoms persist or flare up without achieving remission despite existing treatments, Stokes said, adding that the company is committed to working with healthcare professionals and health authorities to bring Omvoh to ulcerative colitis patients in Korea rapidly.

In the LUCENT-1 and 2 trials, the most commonly reported adverse events associated with Omvoh were upper respiratory tract infections (including nasopharyngitis), headache, rash, and injection site reactions.