Date: 2013-03-02
Type of
information: Presentation of results at a congress
phase: 1b
Announcement: presentation of results at the 71st Annual Meeting of the American Academy of Dermatology (AAD) in Miami
Company: Sanofi (France) Regeneron Pharmaceuticals (USA)
Product: dupilumab
Action
mechanism:
- monoclonal antibody. Dupilumab (SAR231893/REGN668) is an investigational, high-affinity, subcutaneously administered, fully-human antibody targeting the alpha subunit of the interleukin 4 receptor (IL-4R alpha), By blocking IL-4R alpha dupilumab modulates signaling of both IL-4 and IL-13, drivers of a Th2 immune response. Dupilumab was created using Regeneron's VelocImmune® technology and is being co-developed with Sanofi.
Disease: atopic dermatitis
Therapeutic
area: Dermatological diseases - Immunological diseases - Inflammatory diseases
Country: Australia, Germany, New Zealand
Trial
details:
- The Phase 1b trials included 67 patients randomized to three different doses of dupilumab (75mg, n=8; 150mg, n=22; 300mg, n=21) and placebo (n=16). The primary objective of the Phase 1b studies was to assess the safety profile of dupilumab. Other endpoints included pharmacokinetic, biomarker, and efficacy parameters. Following the 4-week treatment period, patients in the studies were followed for an additional 4 weeks for a total of 8 weeks. (NCT01385657)
Latest
news:
- • On March 2, 2013, Sanofi and Regeneron Pharmaceuticals have announced that pooled data from two Phase 1b trials with dupilumab (REGN668/SAR231893),were presented at the 71st Annual Meeting of the American Academy of Dermatology (AAD) in Miami. The primary objective of the Phase 1b studies was to assess the safety profile of dupilumab. Other exploratory endpoints included pharmacokinetic, biomarker, and efficacy parameters. The efficacy data showed that treatment with four weekly subcutaneous injections of dupilumab at either 150 milligrams (mg) or 300mg per week, significantly improved the signs and symptoms of patients with moderate-to-severe atopic dermatitis (AD) whose disease was not adequately controlled with topical medications. Specifically, patients treated with dupilumab had significant improvements in body surface area (BSA) score, Investigator Global Assessment (IGA) score, and Eczema Area Severity Index (EASI) from baseline to week 4 compared to placebo (p < 0.05 vs. placebo for all measures and doses). The significant improvements in BSA, IGA, and EASI scores were maintained at week 8 in the 300mg dose group (p < 0.05 vs. placebo). A responder analysis demonstrated that at week 4, 54.5% of patients treated with the 150mg dose and 71.4% of patients treated with the 300mg dose achieved a reduction in EASI score of 50% or greater compared to 18.8% with placebo (p < 0.05). The most common adverse events (AEs) were nasopharyngitis (19.6% vs 12.5% for placebo) and headache (11.8% vs 6.3% for placebo).
Is
general: Yes
