Evolva receives clearance to move EV-077 into Phase IIa
- 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 randomised, 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.
Most read news
Other news from the department research and development
Get the life science industry in your inbox
From now on, don't miss a thing: Our newsletter for biotechnology, pharma and life sciences brings you up to date every Tuesday and Thursday. The latest industry news, product highlights and innovations - compact and easy to understand in your inbox. Researched by us so you don't have to.