French pharmaceutical firm Sanofi and US-based Regeneron Pharmaceuticals have reported positive results from a Phase IIb dose-ranging trial of an investigational therapy ‘dupilumab’, in adult patients with moderate-to-severe atopic dermatitis (AD), a serious, chronic form of eczema.
Dupilumab is an investigational monoclonal antibody that blocks signalling of IL-4 and IL-13, two cytokines that play a major role in the pathogenesis of moderate-to-severe atopic dermatitis.
In the trial, all doses of dupilumab met the primary endpoint of a greater improvement in Eczema Area and Severity Index (EASI) scores from baseline compared to placebo.
Regeneron chief scientific officer and Regeneron Laboratories president George Yancopoulos said: "Blocking IL-4/IL-13 signaling may provide an important new approach to atopic conditions, including asthma, atopic dermatitis and nasal polyposis, where we have ongoing clinical programs."
All five subcutaneous doses of dupilumab showed a dose-dependent improvement in the trial’s primary endpoint, which is the mean percent change in EASI score from baseline to week 16.
The most common adverse event observed in the Phase IIb trial was nasopharyngitis, which was balanced across dupilumab treatment groups compared to placebo.
The company said that injection site reactions were more frequent in the dupilumab group compared to placebo, as was headache compared with placebo.
Sanofi president of Global R&D Elias Zerhouni said: "These latest results are consistent with what was observed in the earlier clinical studies and add to the body of evidence that investigational dupilumab may have a role to play for patients with moderate-to-severe atopic dermatitis.
"We are now able to select the optimal doses for the Phase III studies, which we anticipate to begin later this year."
Around 380 patients with moderate-to-severe atopic dermatitis, who could not be adequately controlled with topical medication or for whom topical treatment was not advisable, were enrolled in the double-blind, placebo-controlled, 16-week, dose-ranging Phase IIb trial.
In the trial, patients were randomised to receive one of five doses of dupilumab (300mg weekly, 300mg every other week, 300mg monthly, 200mg every other week, 100mg monthly) or placebo.
Image: Atopic dermatitis of the anterior flextural crease of the elbow. Photo: courtesy of James Heilman, MD.