Intensifying competition in ulcerative colitis drug market

Lilly’s IL-23 inhibitor Omvoh wins approval in Korea and will compete against Stelara

New S1P modulators have demonstrated efficacy in clinical trials, and JAK inhibitors are being evaluated in clinical trials

New drug development for conquering ulcerative colitis drives competition among global pharmaceutical companies.

 

Competition in the market will likely intensify due to the efficacy shown by new drugs, including JAK inhibitors Rinvoq and Xeljanz, anti-integrin drugs, and S1P receptor modulators, in clinical trials, in addition to biological medicine Omvoh, a recently approved drug.

 

While TNF-alpha inhibitors such as Humira and Remicade currently dominate the market for ulcerative colitis, the market landscape is forecasted to change.

 

Omvoh, Eli Lily’s interleukin (IL)-23 inhibitor, has been approved in Korea, the industry said on the 27th.

 

Omvoh can treat patients with ulcerative colitis who have previously had failed response to corticosteroids or immunomodulators.

 

Omvoh selectively binds to the p19 subunit of IL-23 and offers a targeted treatment mechanism for the disease.

 

The efficacy of Omvoh was confirmed in Phase 3 LUCENT-1 and 2 clinical trials that included patients with moderately active ulcerative colitis.

 

The clinical trials enrolled patients who had inadequate response to corticosteroids, immunomodulators, or one or more biological medicines.

 

The patients were randomized to receive Omvoh or placebo, starting with a 12-week intravenous administration followed by a 40-week maintenance therapy through subcutaneous injection.

 

The clinical results have shown that the Omvoh group demonstrated a clinical remission rate of 24.2% compared to 13.3% in the placebo group.

 

The Omvoh group achieved 27.1% in histologic-endoscopic mucosal improvement (HEMI), a significant improvement compared to 13.9% in the placebo group.

 

Based on the results after evaluating 544 patients who underwent a 40-week maintenance therapy, 49.9% of patients in the Omvoh group achieved clinical remission, compared to 25.1% of the placebo group, demonstrating Omvoh’s efficacy.

 

Regarding the safety of Omvoh, the most common adverse reactions associated with Omvoh were respiratory infections (7.9%), headaches (3.3%), and rash (1.1%).

 

Omvoh will likely compete with Janssen’s Stelara, an IL-12 and IL-23 inhibitor.

 

Stelara is indicated for Crohn’s disease, besides ulcerative colitis.

 

Eli Lily, the company responsible for developing Omvoh, is currently evaluating Omvoh for Crohn’s disease in clinical trials.

 

Skyrizi, an interleukin-23(IL-23) inhibitor.

In addition to Omvoh, the company is also working on securing indications of interleukin inhibitors for treating ulcerative colitis.

 

Abbvie is also developing Skyrizi, an interleukin-23(IL-23) inhibitor like Omvoh, for the treatment of ulcerative colitis.

 

Skyrizi received approval in Korea only for Crohn’s disease.

 

Both the INSPIRE study, which evaluated the effectiveness of induction therapy at 12 weeks, and the Phase 3 COMMAND clinical study, which evaluated maintenance therapy at 52 weeks, demonstrated Skyrizi’s effectiveness compared to the placebo group.

 

Janssen is developing Tremfya, an IL-23 inhibitor, for the treatment of ulcerative colitis.

 

In the Phase 2 clinical study, Tremfya’s clinical response was achieved in 80% of Tremfya-treated patients.

 

Janssen is conducting a multinational Phase 3 clinical study in patients with active ulcerative colitis.

 

S1P receptor modulators have also proven effective, in addition to JAK inhibitors and anti-integrin drugs In addition to interleukin inhibitors, JAK inhibitors, and anti-integrin drugs have secured indications for ulcerative colitis.

 

JAK inhibitors work by blocking the activity of JAK, a kinase that regulates immunity and inflammation.

 

This mechanism of action is effective in reducing inflammation.

 

JAK inhibitors are used to treat autoimmune diseases such as ulcerative colitis, rheumatoid arthritis, atopic dermatitis, and inflammatory bowel disease.

 

Eisai’s Jyseleca, Pfizer’s Xeljanz, and Abbvie’s Rinvoq.

Among the JAK inhibitors that have received approval in Korea, the medicines that have secured indications for ulcerative colitis are Abbvie’s Rinvoq, Eisai’s Jyseleca, and Pfizer’s Xeljanz.

 

These drugs are undergoing clinical trials to evaluate their effectiveness as maintenance therapy for ulcerative colitis.

 

Takeda’s Kynteles, an anti-integrin drug, has secured an indication for ulcerative colitis.

 

Kynteles inhibits the migration of lymphocytes, which causes inflammation, into the gastrointestinal tract.

 

Recently, the sphingosine-1-phosphate (S1P) receptor modulator has entered the market.

 

Pfizer’s Velsipity recently received approval in Europe after securing approval in the United States last year.

 

Inhibition of the S1P receptor can reduce the leakage of lymphocytes circulating in the lymph nodes, thereby diminishing inflammatory responses.

 

Velsipity demonstrated efficacy in patients with ulcerative colitis who have previously had a failed response or intolerance to one or more treatments.

 

Velsipity has shown effectiveness in patients who have had an inadequate response to at least one or more biologic or Janus kinase JAK inhibitor therapy compared to the placebo.

 

It has been shown that there are improvements in endoscopic outcomes, alleviation of symptoms, and a restoration of the intestinal barrier.

 

Velsipity aims to compete with BMS’s similar S1P receptor modulator, Zeposia.

 

Zeposia, which received approval in Korea last year, secured reimbursement this year and launched in the market.

 

It has landed in general hospitals, where prescriptions are being actively written.