Allergan plc, a global pharmaceutical company 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-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. SEQUOIA and CEDAR clinical trials continue on a masked basis for a second year.
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.
David Nicholson, Chief Research and Development Officer, Allergan said, “In both studies abicipar demonstrated remarkable efficacy in the 8-week and 12-week regimens. We believe the SEQUOIA and CEDAR studies demonstrated what we set out to achieve, strong efficacy and duration of effect which shows the potential of abicipar as a treatment for AMD patients. We have generated important findings in these trials to address a serious unmet need.”
Raj Maturi, MD, Midwest Eye Institute & Associate Professor Ophthalmology, Indiana University School of Medicine said, “Today’s anti-VEGFs were designed for monthly or bimonthly dosing. In the real world, patients have difficulty adhering to the schedule. The adopted treat-and extend approach in certain cases shows sub-optimal visual outcomes. Abicipar could be the first and only 12- week anti-VEGF treatment that improves visual outcomes in a real world setting for a large number of AMD patients,”
Patrick Amstutz, PhD, CEO of Molecular Partners”We are very excited to see that the most advanced DARPin® molecule, abicipar, reaches its primary endpoint in phase 3. This is a very important milestone for Molecular Partners and the DARPin® technology in general.