JDRF, iCo Therapeutics partner for iCo-007 Phase II trial in DME

iCo Therapeutics (TSX-V: ICO), a Vancouver-based drug reprofiling company and JDRF, the largest charitable funder of type 1 Diabetes (T1D) research have joined forces to investigate a potential new treatment for one of the most common complications of diabetes, diabetic macular edema (DME). The iDEAL study is a Phase II clinical trial to evaluate whether the drug iCo-007 could help to treat DME in people with either T1D or type 2 diabetes. The study is being conducted at the Wilmer Eye Institute of the Johns Hopkins University School of Medicine.

The iDEAL trial explores whether varying combinations and concentrations of iCo-007 are effective in improving visual acuity in people with DME-the leading cause of functional visual loss among working Americans, in which leakage of fluid from blood vessels in the eye causes the retina to swell, leading to blurred vision and blindness. The Phase II clinical trial is a multi-center study chaired by Quan Dong Nguyen, MD, MSc, Associate Professor of Ophthalmology at the Wilmer Eye Institute of the Johns Hopkins University School of Medicine, and will study as many as 208 patients with DME at up to 30 clinical sites across the United States. In addition, the Retinal Imaging Research and Reading Center (RIRRC) at the Wilmer Eye Institute serves as the Reading Center for the iDEAL Study.

"The iDEAL trial for iCo-007 is one of the largest studies of its kind currently investigating DME," said Andrew Rae, President and CEO 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."

"Diabetic macular edema is both devastating and prevalent, and yet today's treatments are insufficient," said Aaron Kowalski, Ph.D., assistant vice president of treatment therapies for JDRF. "JDRF is committed to improving the lives of all people with type 1 diabetes, and this involves accelerating both the development and the delivery of better treatments for the disease and its complications. That is why we have placed retinopathy as a high priority research area, and why collaborations like this one are so important. Should iDEAL be successful, iCo-007 could be introduced as a potential new therapy to help preserve vision in people with diabetes."

The iDEAL study, which is in the process of recruiting participants, follows patients for a 12 month period. During the trial, patients are randomized into one of the following four groups: either one of two mono-therapy 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. To be eligible for the trial, participants must have T1D or type 2 diabetes, baseline visual acuity between 20/32 and 20/320 on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, and DME with central subfoveal thickness greater than 250 microns on optical coherence tomography (OCT).

"Using both a monotherapy as well as combination therapy approach should uncover the potential of this novel drug for treatment of a wider DME patient population," said Peter Hnik, MD, MHSc., Chief Medical Officer of iCo. The primary endpoint of the iDEAL trial is a change in visual acuity from baseline to month eight. Secondary endpoints include: visual acuity at month 12; retinal thickness as measured by OCT at month eight and 12; duration of the effect of iCo-007 at month 12; and safety."