Article
Phase I MP0112 wet AMD study results: DARPin® MP0112 shows potential for quarterly dosing in wet AMD
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Authors
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Carsten Framme
- Universitäts-Augenklinik Bern
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U.E.K. Wolf-Schnurrbusch
- Universitäts-Augenklinik Bern
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M.T. Stumpp
- Molecular Partners AG, Zürich
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S. Wolf
- Universitäts-Augenklinik Bern
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MPO 112 AMD Studiengruppe
| Published: | June 15, 2011 |
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Outline
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Background: 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 3–4 fold compared to current standard therapy. This clinical study assessed the safety and preliminary efficacy of DARPin® MP0112.
Method: The MP0112 wet AMD study is a Phase I/II, open-label, non-controlled, multicentre trial. It consisted of 5 dose (0.04 mg; up to 2.0 mg MP0112) ascending cohorts. Patients with newly diagnosed wet AMD and a BCVA of maximal 20/40 were enrolled. Four to nine patients were included per cohort and received a single dose of MP0112 as intravitreal injection.
Results: Baseline visual acuity in all patients was 56 ETDRS letters (32–72 letters) and improved to 59 ETDRS letters (28–80 letters) after 16 weeks. FA revealed dose-dependent reduction of leakage. In the highest two dose cohorts central retinal thickness measured by SD-OCT was reduced by 95 µm and 111 µm respectively after 4 weeks. In these groups, 8 of 10 patients had no disease progression for 8 weeks, and 7 of 10 patients for even 16 weeks. Fifty perecent of all patients – especially in the low dose groups – required rescue therapy. The most frequent adverse effect was a dose-related transient sterile inflammation that resolved without visual consequences.
Conclusion: 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.
