Positive results have just been announced for a Phase 2 study called QUARTZ2, investigating SHR0302 as a therapy for atopic dermatitis (AD). Researchers found that at every dose level examined, the therapy achieved its primary endpoint (IGA score). Additionally, the secondary endpoint of analyzing eczema severity had a 75% improvement by week 12.
AD
AD is a chronic skin condition that can present in many ways with a wide array of symptoms. These symptoms may include dry, itchy, cracked, or red skin. AD significantly impacts patients quality of life and there is a need for more effective and affordable treatments for this condition.
QUARTZ2 Study
The QUARTZ2 trial was a randomized and double-blind trial investigating SHR0302 compared to placebo for AD patients. The study was conducted in China at 23 different sites.
All participants in this trial were adults with moderate to severe disease. A total of 105 patients were included. Patients were randomized to receive one of two doses of the therapy (8 or 4 mg) or placebo. The treatment lasted 12 weeks. Some of the notable results include-
- IGA score (primary endpoint) of clear or almost clear (54.3% for 8mg treatment group and 25.7% for 4mg treatment group, compared to 5.7% of placebo).
- Improvements in itch symptoms (60% for 8mg, 42.9% for 4 mg, and 8.6% for placebo)
- Improvements in eczema scores (74.3% for 8mg, 51.4% for 4mg, and 22.9% for placebo)
- Positive safety results, consistent with JAK1 inhibitors
SHR0302
SHR0302 is a JAK1 inhibitor currently being investigated in many studies for an array of inflammatory and immune conditions. For example, JAK1 is being examined in Crohn’s disease and ulcerative colitis, and it will soon move to a Phase 3 study for AD.
Researchers believe this therapy could be more beneficial (in terms of both safety and efficacy) compared to pan-JAK inhibitors because it is highly selective.
You can read more about this investigative therapy in atopic dermatitis here.
