A late-stage study of Sanofi and Regeneron’s Dupixent in adolescents with atopic dermatitis has met its key targets, paving the way for a regulatory submission for drug targeting this younger patient group in the third quarter.
The trial assessed Dupixent (dupilumab) in 251 patients who were aged 12 to 17 with moderate-to-severe atopic dermatitis, who were either not responding to or were unable to receive topical treatment.
The primary endpoints were the proportion of patients achieving Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) and 75 percent improvement in Eczema Area and Severity Index (EASI-75, co-primary endpoint outside of the US) at 16 weeks.
The data showed that 24 percent of patients who received weight-based dosing of Dupixent every two weeks and 18 percent of those given a fixed dose every four weeks achieved the primary endpoint of clear or almost-clear skin, versus 2 percent in the placebo arm.
Also, 41.5 percent of those who received Dupixent every two weeks and 38 percent of patients who took the drug every four weeks achieved 75 percent or greater skin improvement (EASI-75) compared to 8 percent in the control group.
On the safety side, the overall rate of adverse events was comparable between the Dupixent groups and placebo (72 percent for Dupixent every two weeks, 64 percent for Dupixent every four weeks and 69 percent for placebo) over the 16-week treatment period, while there were no serious adverse events or events leading to treatment discontinuation in either drug treatment group, Sanofi said.
Elias Zerhouni, president, Global R&D at Sanofi, noted that current treatment options for adolescents with the condition such as topical steroids, oral steroids, and non-steroidal immunosuppressants “can have significant side effects," and that Dupixent could potentially provide adolescent patients with “a therapy that treats more than just their symptoms."
Dupixent is a human monoclonal antibody designed to specifically inhibit overactive signaling of two key proteins - IL-4 and IL-13 -believed to be major drivers of the persistent underlying inflammation in AD, and certain other allergic or atopic diseases.
The drug was approved for adults were atopic dermatitis in September last year, after data from the Phase III LIBERTY AD CHRONOS trial showed its addition to topical corticosteroids significantly improved measures of overall disease severity.
The data on its use in adolescents will be submitted to regulatory authorities later this year, with a US submission for patients aged 12-17 planned for third quarter.