After announcing positive results from a Phase 2b ADVISE trial, Arena Pharmaceuticals, Inc. (“Arena”) hopes to soon initiate a Phase 3 clinical trial to evaluate etrasimod as a treatment for patients with severe atopic dermatitis. The orally administered therapy has been shown to be both safe and effective. Now, the Phase 3 trial will inform further drug development.
Etrasimod
Etrasimod is a sphingosine 1-phosphate (S1P) receptor modulator. Because it is considered investigational, it is not yet approved for use. However, researchers hope that it can one day be used not only for atopic dermatitis, but other conditions such as ulcerative colitis (UC) and eosinophilic esophagitis.
In the Phase 2b ADVISE trial, Arena evaluated the safety, efficacy, and tolerability of etrasimod. 140 participants enrolled. Because the trial was multi center, studies were conducted in both North America and Australia. Researchers analyzed how etrasimod impacted the Eczema Area and Severity Index (EASI) over a 12-week period and 4-week observation.
While taking 2 mg etrasimod, approximately 33% of participants experienced clear (or nearly clear) skin. The therapy also helped to reduce itching caused by inflamed skin. Additionally, researchers found the drug to be relatively safe and well-tolerated.
Researchers will continue to analyze the benefits and impact of etrasimod in the Phase 3 clinical trial.
Atopic Dermatitis
According to the National Eczema Foundation, atopic dermatitis is the most common form of eczema, affecting nearly 10 million children and 16.5 million adults in America. The Foundation continues:
In people with AD, for complex reasons science hasn’t fully sorted out, the immune system becomes disordered and overactive. This triggers inflammation that damages the skin barrier, leaving it dry and prone to itching and rashes that may appear purple, brown or grayish hue in darker skin tones and red in lighter skin tones.
Some research has linked specific gene mutations to atopic dermatitis. These mutations may cause the skin to lack filaggrin, a protein that keeps our skin safe, healthy, and moisturized. Although atopic dermatitis may initially appear in infancy or early childhood, it often lasts throughout one’s life. Symptoms and characteristics include:
- Dry skin
- Severe itching that worsens at night
- Poor sleep
- Lichenification, or skin thickening or scaling
- Skin discoloration
- Small bumps that might ooze or crack
- Raw, sensitive skin
