Abicipar is a DARPin® based 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.
Molecular Partners and Allergan entered into a broad discovery alliance in ophthalmology in 2012 aiming to develop novel multi-DARPin® molecules for diseases with high unmet medical need. This alliance broadened the initial collaboration on abicipar.
Allergan exercised three options to develop and commercialize DARPin® product candidates from its 2012 discovery alliance agreement with Molecular Partners. Under the discovery alliance, Molecular Partners is responsible for generating the DARPin® product candidates and Allergan will lead the development and will bear all related development costs.