Pfizer Inc. (NYSE: PFE) has announced topline results from its most recent late-stage study in children aged 3 months to less than 24 months with mild to moderate atopic dermatitis (AD), also known as eczema, a chronic skin disease characterized by inflammation of the skin and skin barrier defects.
The data from the trial support the primary study objective to examine the safety of crisaborole ointment, 2%, in this patient population and is consistent with previous clinical trial experience. Crisaborole ointment, 2%, is currently approved in select countries for mild to moderate AD in patients two years of age and older.
The primary endpoints of this CrisADe Care 1 study were the number of patients with treatment-emergent adverse events and severe adverse events and the number of patients with clinically significant changes from baseline in height, weight, vital signs, electrocardiogram and clinical laboratory parameters.
The crisaborole ointment is currently approved in the United States and Canada as Eucrisa for patients two years of age and older.
Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development, commented:
This study reinforces our commitment to young AD patients worldwide who need more options. These results add to the growing body of evidence that underscores the strength of data for crisaborole as a steroid-free, topical treatment option for people with mild to moderate atopic dermatitis. We look forward to discussing the data with regulatory authorities in the future.
Shares of Pfizer traded up 0.5% at $43.51 early Monday, in a 52-week range of $36.00 to $46.47. The consensus price target is $45.92.