Molecular Partners AG announced today results from the Allergan-sponsored, double-masked stage 3 phase 2 study of the DARPin abicipar pegol, for wet age-related macular degeneration (AMD). The results demonstrate that abicipar pegol provides equal or potentially higher vision gains compared to ranibizumab (Lucentis®) with fewer injections. Further, Allergan announced that full phase III development is anticipated to start in Q2 of 2015.
Abicipar pegol (previously AGN-150998 or MP0112) is a long-acting potent antagonist of vascular endothelial growth factor (VEGF), which is based on the DARPin® technology. Abicipar pegol was licensed to Allergan from Molecular Partners in May 2011.
Christian Zahnd, CEO of Molecular Partners commented: “We are very pleased to see our previous findings confirmed that this DARPin has the potential to bring substantial patient value by potentially providing equal or better efficacy with a more patient-friendly dosing regimen as compared to standard of care. This is a great showcase for our DARPin platform which has potential to deliver differentiated programs not only in ophthalmology, but also in other indications such as oncology. Also, we are very happy to see Allergan’s high commitment to advance the DARPin through an impressive clinical development program.”
Michael Stumpp, CSO of Molecular Partners further added: “We are very happy to have supported Allergan in the development of Abicipar, especially on the manufacturing process. For patients with wet AMD, maximizing vision gain and minimizing the frequency of treatments remain the most important needs. We look forward to sharing these important data with the scientific community at one of the retina meetings later this year.”
Further details of the REACH phase 2 study (stage 3):
In stage 3 of the phase 2 study, the safety, efficacy and duration of action of abicipar pegol was investigated compared to the standard of care for wet AMD, ranibizumab. In the doubleâ€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 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, Optical Coherence Tomography (OCT) data was supportive of the visual acuity data. Although the study was not powered to show statistically significant differences between treatment groups, these data suggest that the DARPin at the 2 mg dose is at least as effective as monthly ranibizumab, with a longer duration of action of the DARPin.
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.
Allergan and Molecular Partners have been working to enhance the manufacturing process for abicipar pegol and Allergan announced that it plans to initiate Phase 3 studies in the second quarter of 2015, when material from the new manufacturing process is available.