gms | German Medical Science

24rd Annual Meeting of the German Retina Society

German Retina Society

17.06. - 18.06.2011, Aachen

Phase I MP0112 wet AMD study results: DARPin® MP0112 shows potential for quarterly dosing in wet AMD

Meeting Abstract

  • Carsten Framme - Universitäts-Augenklinik Bern
  • U.E.K. Wolf-Schnurrbusch - Universitäts-Augenklinik Bern
  • M.T. Stumpp - Molecular Partners AG, Zürich
  • S. Wolf - Universitäts-Augenklinik Bern
  • MPO 112 AMD Studiengruppe

German Retina Society. 24th Annual Conference of the German Retina Society. Aachen, 17.-18.06.2011. Düsseldorf: German Medical Science GMS Publishing House; 2011. Doc11rg58

DOI: 10.3205/11rg58, URN: urn:nbn:de:0183-11rg588

This is the translated version of the article.
The original version can be found at: http://www.egms.de/de/meetings/rg2011/11rg58.shtml

Published: June 15, 2011

© 2011 Framme et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.


Outline

Text

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.