AnaptysBio presents updated Phase 2 data for ANB020 in atopic dermatitis
AnaptysBio announced updated data from the company's Phase 2a trial of ANB020, its wholly-owned anti-IL-33 antibody program, in adult patients with moderate-to-severe atopic dermatitis. The Phase 2a proof-of-concept trial assessed ANB020 efficacy and safety in 12 moderate-to-severe adult atopic dermatitis patients. The primary efficacy objective of this study was to determine the percentage of patients achieving 50% improvement in their Eczema Area Severity Index score relative to enrollment baseline on day 29 post-ANB020 administration. Each patient was dosed with placebo 14 days following enrollment, and subsequently administered a single 300mg intravenous dose of ANB020 one week after placebo.Key observations included: ANB020 was efficacious in all 12 patients enrolled in this trial with each patient achieving at least EASI-50 on or before day 57 post-ANB020 administration; Rapid clinical response was observed by day 15 post-ANB020 administration with nine of 12 patients achieving EASI-50, of which three patients also achieved EASI score improvement of 75 percent relative to baseline; Day 29 results exceeded the primary efficacy objective of the trial with 10 of 12 patients achieving EASI-50, of which four patients also achieved EASI-75; Efficacy was sustained through day 140 following single dose administration of ANB020 with five of 12 patients (42 percent) achieving EASI-50, of which three patients (25%) also achieved EASI-75; ANB020 efficacy was not limited by disease severity as ANB020 was similarly efficacious in the seven of 12 enrolled patients treated with systemic immuno-modulators pre-study, which exhibited an average EASI baseline score of 36 upon enrollment, relative to the remaining five of 12 enrolled patients that did not require systemic immuno-modulators pre-study and exhibited an average EASI baseline score of 27; ANB020 was generally well-tolerated by all patients and no drug-related safety signals were observed. The most frequent adverse events reported were dizziness in 17% of patients post-placebo and headache in 25% of patients post-ANB020 administration. A single serious adverse event of depression was reported on Day 140 post-ANB020 administration, which was consistent with the patient's pre-trial history of depression and was deemed not drug-related. During the first half of 2018, AnaptysBio plans to initiate a Phase 2b randomized, double-blinded, placebo-controlled clinical trial in 200-300 adult patients with moderate-to-severe atopic dermatitis to evaluate various dose levels and dosing frequencies of subcutaneously-administered ANB020, with data expected in 2019.