April 2011
Volume 52, Issue 14
Free
ARVO Annual Meeting Abstract  |   April 2011
Single Ascending Doses of DARPin®, MP0112, Show Potential for Quarterly Dosing in DME
Author Affiliations & Notes
  • Manjula Patel
    Numa LLC., Mystic, Connecticut
  • Brian B. Berger
    Brian B Berger MD PA and Associates, Austin, Texas
  • Jeffrey S. Heier
    Ophthalmic Consultants of Boston, Boston, Massachusetts
  • David M. Brown
    Retina Consultants of Houston, Houston, Texas
  • Peter A. Campochiaro
    Ophthalmology, Johns Hopkins Wilmer Eye Inst, Baltimore, Maryland
  • Michael T. Stumpp
    Molecular Partners AG, Zurich, Switzerland
  • Footnotes
    Commercial Relationships  Manjula Patel, Molecular Partners AG (C); Brian B. Berger, Allergan Inc. (C), Bausch + Lomb Inc. (C), Genentech Inc. (F), GlaxoSmithKline Inc. (F, C), Molecular Partners AG (F), Pfizer Inc. (F); Jeffrey S. Heier, Alimera Sciences (F, C), Allergan Inc. (F, C), Fovea Pharmaceuticals (F, C), Genentech Inc. (F, C), Molecular Partners AG (F), Novagali Pharma (F, C), Regeneron Inc. (F, C); David M. Brown, Alcon Inc. (F, C), Alimera Inc. (F), Allergan Inc. (F, C), Genentech Inc. (F, C), Molecular Partners AG (F), Novartis Inc. (F, C), Regeneron Inc. (F, C); Peter A. Campochiaro, Alimera (C), Bristol Myers Squibb Inc. (not current) (F), Genentech Inc. (F, C), Genzyme (C), GlaxoSmithKline Inc. (F, C), LPath Inc. (F), Molecular Partners AG (F), Pfizer Inc (F), Regeneron Inc. (F); Michael T. Stumpp, Molecular Partners AG (E, P)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science April 2011, Vol.52, 582. doi:
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      Manjula Patel, Brian B. Berger, Jeffrey S. Heier, David M. Brown, Peter A. Campochiaro, Michael T. Stumpp; Single Ascending Doses of DARPin®, MP0112, Show Potential for Quarterly Dosing in DME. Invest. Ophthalmol. Vis. Sci. 2011;52(14):582.

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Abstract

Purpose: : DARPins ® are a novel class of small, single domain proteins which can be selected to bind any given target with high affinity and specificity. MP0112 is a potent VEGF inhibitor with a long ocular half-life. Animal studies indicate that dosing frequency in patients may be reduced 3-4 fold compared with current standard therapy.This clinical study assessed the safety and preliminary efficacy of DARPin® MP0112 during 16 weeks in patients with DME.

Methods: : This is a Phase I/II, open-label, non-controlled, trial in the US. Eligible patients were aged >50 years with long-standing DME. Six patients were included per cohort in 3 ascending cohorts to receive a single dose of MP0112 via intravitreal injection. Safety and efficacy assessments over the 16-week period included adverse events, BCVA and OCT.

Results: : Eighteen subjects were enrolled at 4 participating sites in the US. The mean age was 65 years with 61% of patients being males. The majority of patients enrolled had received multiple prior treatments with Laser, Avastin, Kenolog and/or Lucentis for DME in the study eye.MP0112 was safe and well tolerated. The most frequent adverse event was a transient, sterile inflammation that resolved without visual consequences. Initial results from an interim analysis conducted for the first 15 patients completing the 16-week study time point have shown promising efficacy in spite of the majority of patients having long standing, refractive DME. Six of 15 patients (40%) showed an improvement of 10 or more letters in BCVA at Week 4, Week 12, and Week 16. In addition, 8 of 15 (53%) patients showed an improvement in OCT of greater than 50 microns at Week 4, and 4 of 15 (27%) patients at week 12 and 16.

Conclusions: : DARPin MP0112 represents a showcase for a novel class of therapeutic proteins in ophthalmology and a promising new long-acting anti-VEGF treatment option for patients with DME as well as other ocular neovascular conditions requiring chronic anti VEGF therapy.

Clinical Trial: : http://www.clinicaltrials.gov NCT01042678

Keywords: edema • diabetic retinopathy • retina 
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