In a recent press release, biopharmaceutical company ASLAN Pharmaceuticals (“ASLAN”) announced that it would begin recruiting patients for an expansion cohort of a clinical trial evaluating ASLAN004 for patients with atopic dermatitis. This move follows an approval by the Data Monitoring Committee (DMC).
ASLAN004
18 patients will enroll in the expansion cohort. These patients will be sourced from at least three separate countries. Within this cohort, patients will receive the highest dose of ASLAN004 given so far in clinical trials. The DMC approval focuses on blinded safety data. However, in lower doses, ASLAN004 was relatively safe and well-tolerated. ASLAN does hope to share full safety data from all four cohorts by the middle of 2021.
In this Phase 1 clinical trial, the original cohorts received either a placebo or 200mg, 400mg, or 600mg subcutaneous ASLAN004. The treatment is a monoclonal antibody that binds to IL-13 receptor α1 subunit (IL-13Rα1). After binding to this, it inhibits pro-inflammatory cytokines IL-4 and IL-13. According to the Mayo Clinic, monoclonal antibodies are:
laboratory-produced molecules engineered to serve as substitute antibodies that can restore, enhance or mimic the immune system’s attack on [specific] cells.
In this case, ASLAN004 prevents the pro-inflammatory cytokines from stimulating itching, redness, or other uncomfortable symptoms of atopic dermatitis.
Atopic Dermatitis
The National Eczema Foundation describes atopic dermatitis as:
the most common type of eczema, affecting more than 9.6 million children and about 16.5 million adults in the United States. In people with AD, for complex reasons science hasn’t fully sorted out, the immune system becomes disordered and overactive, [triggering] 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 suggests that patients with atopic dermatitis have gene mutations that interrupt the development of filaggrin, a protein that helps maintain a protective barrier over the top layer of skin. Patients with atopic dermatitis often experience initial symptoms in infancy or early childhood. Additionally, while symptoms may not progress, others will experience “flares” or episodes way into adulthood. Atopic dermatitis is much more common in those with a history of asthma or allergies. Symptoms include:
- Intense itching
- Sleep disturbances
- Sore or painful skin
- Oozing, weeping, or bleeding skin
- Frequent skin infections
- Skin dryness and discoloration
