Allergan and Molecular Partners Announce Two Positive Phase 3 Clinical Trials for Abicipar pegol 8 and 12-week Regimens for the Treatment in Patients with Neovascular Age-Related Macular Degeneration
DUBLIN, IRELAND – July 19, 2018– Allergan plc, (NYSE: AGN), a leading global pharmaceutical company and Molecular Partners (SIX: MOLN), a clinical-stage biopharmaceutical company developing a new class of drugs known as DARPin® therapies, today 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-naïve patients with neovascular age-related macular degeneration (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. The incidence of intraocular inflammation was higher in the abicipar arms compared to ranibizumab-treated patients in both trials. We are further analyzing these results. SEQUOIA and CEDAR clinical trials continue on a masked basis for a second year.
The filing for abicipar is planned for the first half of 2019. Allergan will be requesting a meeting with the Food and Drug Adminstration (FDA) to discuss our BLA submission.
In the SEQUOIA study, the proportion of patients with stable vision in abicipar dosed Q8 was 94.8 percent, in Q12 was 91.3 percent compared to ranibizumab dosed Q4 96.0 percent.
In CEDAR, the proportion of patients with stable vision in the abicipar dosed Q8 was 91.7 percent, in Q12 was 91.2 percent compared to ranibizumbab dosed Q4 95.5 percent.