Results from phase IIb trial assessing tralokinumab for the treatment of atopic dermatitis
On March 3, 2016, Phase IIb safety and efficacy data assessing the use of MedImmune’s tralokinumab in adult patients with moderate-to-severe atopic dermatitis (AD) were presented at the 75th Annual American Academy of Dermatology (AAD) meeting. Tralokinumab is a human monoclonal antibody that specifically neutralizes interleukin 13 (IL-13), a cytokine that is evidenced to play a role in the pathophysiology of AD and asthma. The AD disease space lacks novel systemic therapies that target underlying molecular pathways rather than systemic relief. There are currently no approved biologics for this indication that specifically inhibit the IL-13 cytokine, marking significant opportunity for tralokinumab, which would gain first to market advantage if approved.
In the Phase IIb double-blind, dose-ranging, placebo controlled trial, 204 patients were randomized to receive 45mg, 150mg, or 300mg of tralokinumab or placebo for 12 weeks following a two week run-in period with topical corticosteroids. At Week 12, Eczema Area and Severity Index (EASI) was significantly reduced from baseline in patients receiving 150mg and 300mg of tralokinumab (-4.4, p=0.027 and -4.9, p=0.011, respectively) compared with placebo. Significantly more patients treated with both 150mg and 300mg of tralokinumab achieved Scoring of Atopic Dermatitis (SCORAD) 50 at Week 12 compared with placebo (p=0.007 for both). Further, a greater number of patients receiving 250mg and 300mg of tralokinumab demonstrated an Investigator’s Global Assessment (IGA) response of zero or one at Week 12 compared with placebo.
In addition, serum dipeptidyl peptidase 4 (DPP-4) has been evidenced as a predictive biomarker for tralokinumab in patients with severe asthma. In a subgroup of patients treated with 300mg of tralokinumab and demonstrating high levels of DDP-4, significant improvements in primary efficacy endpoints were seen in comparison with placebo, and the observed effect sizes were greater than that observed in the intent-to-treat population. DDP-4, therefore, may be used as a predictive biomarker for patients who will benefit from tralokinumab, marking a win for MedImmune.