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Sebastian Wolf, Eric H. Souied, Martine Mauget-Faysse, Francois Devin, Manjula Patel, Ute E. Wolf-Schnurrbusch, Michael Stumpp, MP0112 wet AMD study group; Phase I Mp0112 Wet AMD Study: Results Of A Single Escalating Dose Study With DARPin® MP0112 In Wet AMD. Invest. Ophthalmol. Vis. Sci. 2011;52(14):1655.
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To report the safety and preliminary efficacy of DARPin® MP0112 in patients with wet AMD. DARPins® are a new class of small proteins with very attractive therapeutic properties. The clinical study with DARPin® MP0112 assessed the safety and preliminary efficacy measured by visual acuity (VA), fluorescein angiography (FA), and color fundus photography during 16 weeks.
DARPin® MP0112 is an extremely potent VEGF inhibitor with very long ocular half-life. Animal studies indicate that dosing frequency in patients may be reduced 3-4fold compared to current standard therapy. The MP0112 wet AMD study is a Phase I/II, open-label, non-controlled, multicentre trial. The MP0112 wet AMD study consisted of 5 dose (0.04 mg; 0.15 mg; 0.4 mg; 1.0 mg; 2.0 mg MP0112) ascending cohorts. Eligible patients were aged >50 years with diagnosed wet AMD who are treatment naïve and have a BCVA of 20/40 to 20/320 in the study eye at 4 meters. Four to nine patients were included per cohort and received a single dose of MP0112 as intravitreal injections.
Overall, MP0112 was safe and well tolerated. VA at baseline ranged from 32 to 72 ETDRS letters (median: 64 ETDRS letters). At the end of the 16 weeks follow-up all patient had stable or increased VA. At the 4 week visit, a total of 16 patients (50%) received rescue therapy. In the highest two dose groups, 8 of 10 patients had no disease progression for 8 weeks, and 7 of 10 patients for even 16 weeks. The most frequent adverse effect was a dose-related transient sterile inflammation that resolved without visual consequences.
The results of this Phase I dose-escalation study demonstrate overall safety and efficacy of MP0112. The higher MP0112 doses show potential for quarterly dosing for the treatment of wet AMD. DARPin MP0112 represents a very promising new anti-VEGF treatment option with potential in various retinal diseases and is a showcase for a novel class of therapeutic proteins in ophthalmology.
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