Sanofi and Regeneron Pharmaceuticals announced Friday that two Phase III studies of the experimental drug dupilumab in adults with inadequately controlled moderate-to-severe atopic dermatitis (AD) met their primary endpoints. Elias Zerhouni, president of global R&D at Sanofi, said "in the US, where dupilumab in AD has been granted breakthrough therapy designation by the...FDA, we plan to submit a regulatory application in the third quarter of this year."
The LIBERTY AD SOLO 1 and SOLO 2 trials enrolled a total of 1379 adults with moderate-to-severe AD who were not adequately controlled with topical medications, or if topical treatment was not medically advisable. Patients were randomised into one of three treatment groups: dupilumab 300 mg subcutaneously once per week, dupilumab 300 mg subcutaneously every two weeks, or placebo for 16 weeks following an initial dupilumab loading dose of 600 mg subcutaneously, or placebo.
Results at 16 weeks showed that dupilumab significantly improved measures of overall disease severity, skin clearing, itching, quality of life and mental health versus placebo. In SOLO 1 and SOLO 2, respectively, 37 percent and 36 percent of patients who received dupilumab weekly, and 38 percent and 36 percent of patients who were given dupilumab every two weeks, achieved clearing or near-clearing of skin lesions, compared to 10 percent and 8.5 percent with placebo. Sanofi and Regeneron noted that this was the main goal of the study in the US.
Further results demonstrated that in SOLO 1 and SOLO 2, respectively, the percent improvement in the Eczema Area and Severity Index (EASI) from baseline was 72 percent and 69 percent in patients who received dupilumab weekly, and 72 percent and 67 percent for those administered dupilumab every two weeks, versus 38 percent and 31 percent for placebo. In addition, for SOLO 1 and SOLO 2, respectively, 52.5 percent and 48 percent of patients who received dupilumab weekly, and 51 percent and 44 percent of those given dupilumab every two weeks, achieved EASI-75, compared to 15 percent and 12 percent with placebo.
Sanofi and Regeneron added that during the 16-week treatment period, the overall rate of adverse events was comparable between the dupilumab and the placebo groups, at 65 percent to 73 percent and 65 percent to 72 percent, respectively. Meanwhile, the rate of serious adverse events was 1 percent to 3 percent for dupilumab and 5 percent to 6 percent for placebo.
"These are the first Phase III studies of a systemic therapy to demonstrate a significant improvement in moderate-to-severe AD," remarked George D. Yancopoulos, Regeneron's chief scientific officer. The companies indicated that more detailed results from the trials will be submitted for presentation at a future medical congress.
According to Sanofi and Regeneron, there are about 1.6 million patients with moderate to severe AD in the US who don't respond well to existing treatments. Analysts from Cowen & Co. and RBC Capital Markets have described the AD market as "very lucrative," while Sanofi's management has suggested that dupilumab could be a blockbuster drug with multiple uses. Some analysts expect the drug to cost up to $30 000 a year and to eventually generate annual sales of more than $5 billion.
For related analysis, see JP Morgan 2016: Regeneron putting its money where its mouth is on dupilumab.
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