Investigational DME agent nears phase II trial

April 4, 2012

iCo Therapeutics and JDRF, formerly the Juvenile Diabetes Research Foundation, have joined forces in a phase II clinical trial to investigate the investigational drug iCo-007 as a treatment for diabetic macular edema (DME).

Vancouver, British Columbia-iCo Therapeutics and JDRF, formerly the Juvenile Diabetes Research Foundation, have joined forces in a phase II clinical trial to investigate the investigational drug iCo-007 as a treatment for diabetic macular edema (DME).

The iDEAL study will explore whether varying combinations and concentrations of iCo-007 are effective in improving visual acuity in people with DME. The multicenter clinical trial is being coordinated at Johns Hopkins University. It is led by Quan Dong Nguyen, MD, MSc, associate professor of ophthalmology at the Wilmer Eye Institute of the Johns Hopkins University School of Medicine. As many as 208 patients with DME will be studied at up to 30 clinical sites across the United States.

The study is in the process of recruiting participants, who will be followed for 12 months. During the trial, patients will be randomly assigned to one of two monotherapy arms using repeated intravitreal dosing of two different concentrations of iCo-007, or one of two combination arms using iCo-007 with laser photocoagulation or iCo-007 and ranibizumab (Lucentis, Genentech).

To be eligible for the trial, participants must have type 1 or type 2 diabetes, baseline visual acuity between 20/32 and 20/320 on the Early Treatment Diabetic Retinopathy Study chart, and DME with central subfoveal thickness greater than 250 µm on optical coherence tomography (OCT).

The primary endpoint of the iDEAL trial is a change in visual acuity (VA) from baseline to month 8. Secondary endpoints include VA at month 12; retinal thickness as measured by OCT at months 8 and 12; duration of the effect of iCo-007 at month 12; and safety.

iCo-007 is a second-generation antisense drug targeting c-Raf kinase for the treatment of DME and diabetic retinopathy. iCo-007 completed an open-label, dose-escalating phase I trial with safety as the primary endpoint and VA and measures of retinal thickness serving as secondary endpoints.

“The iDEAL trial for iCo-007 is one of the largest studies of its kind currently investigating DME,” said Andrew Rae, president and chief executive officer of iCo Therapeutics. “We believe iCo-007 represents an exciting new treatment paradigm for patients suffering from this disease and we look forward to announcing further updates, in collaboration with JDRF.”

JDRF and iCo Therapeutics expect to provide a further study update, including patient recruitment status, during the second half of this year.

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