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Evolva has received regulatory clearance to progress its pharmaceutical compound EV-077 into Phase IIa clinical studies for the treatment of complications of diabetes.
The mechanism of action of EV-077 means that it can potentially ameliorate or prevent a range of diabetic complications, including loss of kidney function and increased risk of thrombosis.
Conducted in Germany on around 60 patients, the study will be a randomised, double-blind and placebo-controlled, and will investigate the efficacy and safety of EV-077 in type II diabetics with a heightened risk of diabetic vascular complications.
Measurements will include oxidative stress, vascular inflammation, blood flow and platelet reactivity.
Positive read-outs have previously been obtained on selected biomarkers in both healthy volunteers (in the recently completed Phase I studies) as well as in ex-vivo studies on diabetics.
“I am very pleased with the timely regulatory clearance for our next step with EV-077,” said Evolva’s Chief Medical Officer, Dr. Norbert Bender.
“We remain on track for Phase IIa data by mid-2012. We have obtained good interest from several established pharmaceutical companies in the utility of EV-077 in diabetics, and are confident that the Phase IIa data will provide a good basis for future partnering.”