Allergan Seeks Durable Response in Phase 3 DARPin Trial

Competition continues to heat up in the race for more durable therapies for wet AMD as Allergan has completed enrollment for 2 pivotal phase 3 clinical trials for its DARPin drug, abicipar pegol. Abicipar pegol belongs to a new class of genetically engineered antibody mimetic proteins called DARPins and exhibiting highly specific and high-affinity target protein binding. Molecular Partners, a Swiss company that is partnering with Allergan in the development of abicipar pegol, is pioneering this new class of drugs.

The trials, CEDAR and SEQUOIA, are each enrolling 900 patients and will compare abicipar pegol to ranibizumab (Lucentis, Genentech) for wet AMD regarding safety, efficacy, and the potential to dose abicipar pegol every 8 to 12 weeks vs Lucentis every 4 weeks.

The potential for every 12-week abicipar pegol dosing was demonstrated in the phase 2b PALM trial, which studied the drug for DME. Results from Allergan’s 151-patient, phase 2 PALM study showed that abicipar pegol injected every 8 or 12 weeks for DME offered comparable functional and anatomical effects as Lucentis injected monthly. Patients receiving 2 mg abicipar pegol required fewer injections than patients receiving ranibizumab over a 28-week period, according to a news release from Molecular Partners.

Allergan is collaborating with Molecular Partners in the DARPin program. Top-line data for CEDAR and SEQUOIA are expected in 2018.