Incyte Skin Disease Drug Meets Primary Goal In Late-Stage Study In Children

Incyte Corporation INCY released topline results from its Phase 3 TRuE-AD3 study evaluating the safety and efficacy of ruxolitinib cream (Opzelura) in children with atopic dermatitis (AD).

The study met its primary endpoint and showed significantly more patients treated with ruxolitinib cream 0.75% and 1.5% achieved Investigator's Global Assessment Treatment Success (IGA-TS) than patients treated with vehicle control (non-medicated cream). 

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Investigator's Global Assessment Treatment Success (IGA-TS) is defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a two-point improvement from baseline at Week 8. 

The overall safety profile of ruxolitinib cream is consistent with previous data, and no new safety signals were observed. 

The long-term safety portion of the study will continue as planned.

Data from TRuE-AD3 will be submitted for presentation at an upcoming scientific meeting.

AD – the most common type of eczema – is a chronic skin disease in the U.S. that affects an estimated 2-3 million patients ages 2-11 and more than 21 million people 12 years and older1,2. It is characterized by inflammation and itch. 

Opzelura is already approved for skin conditions, vitiligo, and mild to moderate atopic dermatitis in patients 12 years and older.

Price Action: INCY shares are down 1.51% at $61.89 premarket on the last check Wednesday.