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Evolva Receives Clearance to Move EV-077 into Phase IIa
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Evolva Holding SA has announced that it 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) that derive from the following chain of events:
• Diabetic patients have a reduced sensitivity to insulin which increases overall glucose levels in the body
• The increase in glucose increases oxidative stress
• This oxidative stress generates a high level of isoprostanes and prostanoids
• The isoprostanes and prostanoids chronically activate thromboxane receptors, that are located on the vasculature walls and on the surface of platelets
• Activation of the thromboxane receptors increases vascular inflammation and platelet reactivity
• A high level of vascular events and a progressive deterioration of circulatory and renal function are observed.
EV-077 can potentially counteract this deleterious sequence of events.
The Phase IIa study is designed to assess (using biomarkers) the extent to which this hypothesis holds true in type II diabetics. It will be a single-centre study, conducted in Germany.
The intention is to enrol up to 64 evaluable patients. The study will be randomized, double-blind, and placebo-controlled, and 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, as well as markers of the function of organs that are often impaired in diabetes (e.g. kidney, retina).
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.
Evolva’s Chief Medical officer, Dr. Norbert Bender, said: “I am very pleased with the timely regulatory clearance for our next step with EV-077. 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.”
