Abicipar is a DARPinbased anti-angiogenic drug for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Wet AMD is a leading cause of blindness in the developed world and DME is a leading cause of blindness in young adults in developed countries.
Abicipar is an antagonist of Vascular Endothelial Growth Factor A (VEGF-A) that inhibits all relevant subtypes of VEGF-A with very high potency. The combination of small size, high potency and long intra-vitreal half-life offers the potential for less frequent injections (compared to Lucentis®, the current standard of care) and higher gains in visual acuity.
In Phase 2b studies in wet AMD, abicipar was shown to provide at least equal or higher vision gains with the potential for fewer injections in wet AMD compared to standard of care treatment Lucentis® (ranibizumab). Phase 2b data suggests that abicipar could be administered every 12 weeks following loading doses, compared to every 4 weeks for Lucentis.
Phase 3 clinical trials of abicipar for wet AMD started in July 2015, in partnership with Allergan. Enrollment is progressing well and topline results are expected in 2018. For more information on the clinical trials see:
Allergan presented Phase 2 clinical trial data from PALM, a Multicenter, Double Masked Phase 2 Clinical Trial Evaluating Abicipar Pegol for DME at the 2016 American Academy of Ophthalmology Annual Meeting (AAO) in Chicago. Abicipar met its study endpoints and the efficacy of abicipar was shown in all three treatment groups. Over the 28-week trial period, abicipar with a 2-mg dose (and injected every 8 weeks, respectively every 12 weeks, following three monthly loading doses) demonstrated functional (BCVA) and anatomical (CRT) effects comparable with ranibizumab (Lucentis®) which was injected every 4 weeks into each eye.
Overall, the safety profile of abicipar is acceptable. Intraocular inflammation occurred in 7, 5 and 4 patients in the three treatment groups respectively. The first two groups were treated with a 1 mg dose, respective a 2-mg dose of abicipar at an 8 weeks’ injection interval. The third group was treated with a 2-mg dose of abicipar every 12 weeks. The adverse events observed were mostly mild to moderate in severity, and resolved with treatment. These data show the long duration of action of abicipar and support its progression to Phase 3 in DME.
We have developed abicipar in collaboration with Allergan, Inc., one of the leading global specialty biopharmaceutical companies.
In addition to abicipar, together with Allergan we are developing further DARPins for other ocular targets. The multi-VEGF/PDGF DARPin takes an abicipar-like DARPin and adds an anti-PDGF DARPin. This pairing creates a multi-specific therapy that targets the two critical pathways implicated in serious retinal disease.
The multi-VEGF/PDGF DARPin destabilizes the pericytes that protect new blood vessels that form in the eye during wet AMD. By stripping away the pericytes with the anti-PDGF DARPin, the blood vessels are susceptible to anti-VEGF DARPins, causing regression of the new-grown vessels.
This multi-DARPin combines treatment for both anti-PDGF and anti-VEGF in a single molecule, as opposed to the current standard of care, Lucentis, which is solely an anti-VEGF treatment.
Currently, our multi -VEGF/PDGF DARPin is in preclinical studies in partnership with Allergan. This product candidate has the potential to be the first single therapy targeting both VEGF and PDGF pathways to provide improved visual outcomes for all wet AMD patients.