Pfizer and Eli Lilly are forging ahead with ulcerative colitis (UC) research after posting positive results from their respective Phase III studies.
Two big pharma companies are forging ahead with ulcerative colitis (UC) research after posting positive results from their respective Phase III studies.
Pfizer announced the outcomes from two pivotal trials comprising the ELEVATE UC Phase III registrational program that evaluates etrasimod for moderately-to-severely active ulcerative colitis. Etrasimod is an oral, once-a-day, selective sphingosine 1-phospate (S1P) receptor modulator that’s being investigated for a number of indications, including UC, atopic dermatitis, Crohn’s disease, alopecia areata and eosinophilic esophagitis.
The 52-week ELEVATE UC 52 study saw 27% clinical remission in patients who took etrasimod versus just 7.4% in those who were part of the placebo group at week 12, and then 32.1% clinical mission compared with 6.7% at week 52. In the second trial, ELEVATE UC 12, clinical remission was 24.8% in those who received etrasimod compared to 15.2% in those who were given a placebo. Details of the study were presented at Digestive Disease Week 2022.
“Etrasimod could offer a differentiated clinical profile for people living with moderately-to-severely active ulcerative colitis considering the clear benefit it has shown over 52 weeks in a treat-through trial design, its mechanism of action and its unique pharmacologic properties,” Michael Corbo, the chief development officer for inflammation and immunology at Pfizer, said in a statement. “Patients often need multiple options to help manage their disease and there is a significant need for new therapies. In the ELEVATE clinical program, etrasimod has shown an encouraging balance of efficacy and safety that we believe could have a meaningful impact for patients and physicians, if approved.”
Etrasimod was developed by Arena Pharmaceuticals, which Pfizer acquired in March 2022.
Eli Lilly shared possibly an even bigger win at the conference, presenting impressive outcomes from its Phase III LUCENT-2 trial on mirikizumab.
Patients who received the drug had maintained superior and notable improvements after a year compared to those who took a placebo. The study achieved the primary endpoint of clinical remission and all key secondary endpoints, including bowel urgency severity.
Among the participants who responded to the 12-week induction treatment with mirikizumab, 49.9% reported clinical remission after one year versus just 25.1% in the placebo group. About 63.6% of those who achieved remission at week 12 maintained this status after a year compared to the 36.9% who reported the same from taking the placebo. Interestingly, a whopping 97.8% of those who took mirikizumab and achieved clinical remission after a year were not taking corticosteroids for at least three months before the end of the maintenance treatment period.
“We’re thrilled to share patients with UC receiving mirikizumab achieved long-term clinical remission, improvement in hard-to-treat symptoms like bowel urgency, and remission of acute inflammation in the colon. These results are particularly meaningful for patients whose TNF inhibitors, tofacitinib or other biologic therapies have failed them. Lilly leads the way in studying patient-centric outcomes like bowel urgency. We look forward to regulatory decisions next year,” Lotus Mallbris, M.D., Ph.D., vice president of global immunology development and medical affairs at Lilly, said.
The company filed a Biologics License Application with the U.S. Food and Drug Administration and a Marketing Authorization Application with the European Union in the first quarter of 2022 for mirikizumab in UC. The regulators’ decisions are expected in 2023.
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