Allergan and Molecular Partners report 'positive' Phase 3 results for Abicipar
Allergan and Molecular Partners, a clinical-stage biopharmaceutical company developing a new class of drugs known as DARPin therapies, announced the release of two positive clinical trials, SEQUOIA and CEDAR for abicipar, demonstrating that both the 8-week and 12-week treatment regimens met the pre-specified primary endpoint of non-inferiority to ranibizumab. SEQUOIA and CEDAR are identical global phase 3 studies designed to assess the efficacy and safety of abicipar compared with ranibizumab in treatment-naive patients with neovascular age-related macular degeneration, or AMD. The primary endpoint measured the proportion of treated patients with stable vision at week 52. In both studies abicipar demonstrated similar efficacy after 6 or 8 injections, compared to 13 ranibizumab injections in the first year of this study. The overall adverse events were similar among the three treatment arms. SEQUOIA and CEDAR clinical trials continue on a masked basis for a second year. The filing for abicipar is planned for 1H19. Allergan will be requesting a meeting with the FDA to discuss the BLA submission.