December 4, 2022

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Pfizer Oral S1P Modulator for Ulcerative Colitis Meets Primary Endpoint of Phase 3 Trials

Pfizer Oral S1P Modulator for Ulcerative Colitis Meets Primary Endpoint of Phase 3 Trials



 

Pfizer Oral S1P Modulator for Ulcerative Colitis Meets Primary Endpoint of Phase 3 Trials


On March 23, 2022, Pfizer announced positive top-line results from a Phase 3 clinical trials of Etrasimod (ADP334).

Etrasimod is an investigational once-daily oral selective sphingosine 1-phosphate (S1P) receptor modulator being developed for the treatment of moderately to severely active ulcerative colitis (UC).

The trial met its primary endpoint of a statistically significant improvement in clinical remission at week 12 in the Etrasimod group compared to placebo. And, the trial showed significant improvement on all key secondary endpoints.

 

UC is a chronic, often debilitating inflammatory bowel disease. 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.

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. 

With the 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. Among them, S1P receptor modulators are the current research and development hotspot.

 

Etrasimod was developed by Arena Pharmaceuticals, which was acquired by Pfizer in December.

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.

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. 

 

Pfizer Oral S1P Modulator for Ulcerative Colitis Meets Primary Endpoint of Phase 3 Trials

Image source: Pfizer’s official website

 

This multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial enrolled 354 patients with UC who had previously failed or were intolerant to at least one conventional therapy/biologic/JAK therapy.

 

 

 

References:

[1] Pfizer Announces Positive Top-Line Results for Phase 3 Trial of Etrasimod in Ulcerative Colitis Patients. Retrieved March 23, 2022, from https://www.businesswire.com/news/home/20220323005370/en/Pfizer-Announces-Positive-Top-Line-Results-for-Phase-3-Trial-of-Etrasimod-in-Ulcerative-Colitis-Patients

(source:internet, reference only)


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