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Positive phase 2 trial results of anti-VEGF abicipar pegol for treating wet AMD
Analysis of data from a Phase 2 study of abicipar pegol (Anti-VEGF DARPin®) in neovascular, or “wet,” age-related macular degeneration (AMD) showed positive results, leading to the decision to advance abicipar pegol to Phase 3 clinical trials.
The abicipar pegol Phase 2 study was designed to, in addition to assessing safety and efficacy, determine the appropriate dose of abicipar pegol that would provide equal or better visual acuity improvement but require less frequent injections than ranibizumab (LUCENTIS®). In the double-masked trial, a total of 64 patients were randomized to abicipar pegol 1mg (n=25), abicipar pegol 2mg (n=23) or ranibizumab 0.5mg (n=16) and were followed for 20 weeks. All patients received doses at the start of the trial and at 4 and 8 weeks. Patients in the ranibizumab arm of the study received additional doses at 12 and 16 weeks. Patients who were treated with either dose of abicipar pegol received sham injections at 12 and 16 weeks. Patients in all arms of the study were well matched for demographics and baseline characteristics.
The analysis of the topline data showed that after 16 weeks, mean visual acuity improvement from baseline was 8.2 letters for abicipar pegol 2mg, 6.3 letters for abicipar pegol 1mg, and 5.3 letters for ranibizumab. After 20 weeks, (12 weeks after the last abicipar pegol injection and 4 weeks after the last ranibizumab injection) mean visual acuity improvement from baseline was 9.0 letters for abicipar pegol 2mg, 7.1 letters for abicipar pegol 1mg, and 4.7 letters for ranibizumab. In addition, OCT data were supportive of the visual acuity data. Although the study was not powered to show statistically significant differences between treatment groups, and further data will be completed and submitted to the FDA, these data suggest that abicipar at the 2mg dose is at least as effective as monthly ranibizumab with a longer duration of action.
There were no serious adverse events reported in any study group. Two patients in the abicipar pegol 2mg arm and three patients in the abicipar pegol 1mg group experienced ocular inflammation adverse events. The complete data from the Phase 2 study will be presented at a retina meeting in the second half of 2014.
Phase 3 studies will begin in the second quarter of 2015, and will compare abicipar 2mg dosed every 8 weeks, abicipar pegol 2mg dosed every 12 weeks and ranibizumab dosed every 4 weeks. All patients in the phase 3 program will receive three loading doses of drug.