Express Pfizer's S1P receptor modulator received another positive phase 3 clinical result, and plans to start regulatory application submission this year

▎WuXi AppTec Content Team Editor Pfizer announced today that its investigational oral selective sphingosine 1-phosphate (S1P) receptor modulator etrasimod is in Phase 3 treatment of moderate to severe ulcerative colitis (UC).
Positive top-line results in clinical trial ELEVATE UC 52
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This is the second positive phase 3 clinical trial result for etrasimod in one week
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In this 52-week, randomized, double-blind, placebo-controlled Phase 3 trial, 433 patients with ulcerative colitis received either etrasimod or a placebo
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They had been treated with at least one conventional therapy, biologic therapy, or JAK inhibitor
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Etrasimod met the trial's co-primary endpoint, with statistically significant improvements in patients' clinical remission at 12 and 52 weeks of treatment
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There were also statistically significant improvements in all key secondary endpoints at 12 and 52 weeks
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The full results of the trial will be submitted to a scientific journal for publication
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These data, along with results from another previous Phase 3 clinical trial and a long-term extension trial, will form the basis for a regulatory submission, the press release said
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Pfizer expects to initiate regulatory filings this year
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Ulcerative colitis is a chronic, often debilitating inflammatory bowel disease
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Symptoms of the disease can include chronic diarrhea with blood and mucus, abdominal pain and cramping, and weight loss, and have a significant impact on the patient's work, family, and social activities
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At present, the treatment of this disease mainly lies in the inhibition of intestinal inflammation.
However, the existing treatment methods, such as aminosalicylic acid, glucocorticoids, immunosuppressants or biological agents, are not satisfactory in terms of safety and efficacy.
popular
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With the continuous deepening of basic research on the immune system, therapeutic targets related to the mechanism of inflammation have been continuously discovered, and a variety of new targeted drugs have been used in treatment
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Among them, S1P receptor modulators are the current research and development hotspot
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Etrasimod was developed by Arena Pharmaceuticals, which Pfizer completed its acquisition of in March
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Etrasimod is a next-generation oral S1P modulator that specifically binds to S1P receptors 1, 4, and 5 and may have a better efficacy/safety profile
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The investigational therapy is currently being investigated for a range of immune-inflammatory diseases, including UC, Crohn's disease, atopic dermatitis, eosinophilic esophagitis and alopecia areata
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It is worth mentioning that Genting Xinyao owns the development rights of etrasimod in Greater China
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Image source: Pfizer's official website "In patients with moderate-to-severe ulcerative colitis, these latest data further demonstrate the potential benefit of this drug, clearly demonstrating its ability to produce significant remission at 12 weeks and maintain clinical remission at 52 weeks.

" These data show the potential of
etrasimod as a 'best-in-class' therapy, " said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer .
Reference: [1] Pfizer Announces Positive Top-line Results from Yearlong Phase 3 Trial of Etrasimod in Ulcerative Colitis, Underscoring Best-in-Class Potential.
Retrieved March 29, 2022, from https:// /home/20220329005198/enDisclaimer: The WuXi AppTec content team focuses on introducing global biomedical health research progress
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This article is for information exchange purposes only, and the views expressed in this article do not represent WuXi AppTec's position, nor do they represent WuXi AppTec's support or opposition to the views expressed in this article
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This article is also not a treatment plan recommendation
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For guidance on treatment options, please visit a regular hospital
.