Sanofi and Regeneron’s atopic dermatitis candidate dupilumab has turned in a strong performance in late stage clinical trials, showing high levels of efficacy and a solid safety profile in patients with this severe form of eczema.
Two placebo-controlled Phase III studies evaluating the drug in adults with inadequately controlled moderate-to-severe atopic dermatitis met their primary endpoints, showing that the monotherapy significantly improved measures of overall disease severity, skin clearing, itching, quality of life, and mental health.
"These are the first Phase III studies of a systemic therapy to demonstrate a significant improvement in moderate-to-severe atopic dermatitis, a chronic, debilitating inflammatory disease that impacts over one million Americans," said George Yancopoulos, Regeneron’s chief scientific officer. "These data provide strong evidence that the IL-4 and IL-13 signaling pathway is a fundamental driver of inflammation in atopic dermatitis.”
In the SOLO 1 and SOLO 2 trials, 37 and 36 percent (respectively) of patients who received dupilumab 300 mg weekly, and 38 and 36 percent of patients who taking the dose every two weeks, achieved clearing or near-clearing of skin lesions, compared to 10 and 8.5 percent with placebo.
Also, the percent improvement in Eczema Area and Severity Index from baseline was 72 and 69 percent in patients who received the 300mg weekly dose, and 72 and 67 percent in the 300mg every two weeks group, compared to 38 and 31 percent for placebo.
On the safety side, the overall rate of adverse events over the 16-week treatment period was comparable between the dupilumab and the placebo arms of the trial (65-73 percent versus 65-72 percent, respectively). The rate of serious adverse events was 1-3 percent for dupilumab and 5-6 percent for placebo.
The drugmakers said they intend to file the drug in the US in the third quarter of this year. If successful, dupilumab would be the first approved systemic treatment for the condition, helping to address significant unmet need.