Evolva Receives Clearance to Move EV-077 into Phase IIa
|| Print ||
|Monday, 07 November 2011 18:25 (UTC + 1)|
Reinach, Switzerland, 7 November 2011 / B3C newswire / – Evolva Holding SA (SIX: EVE) announced today 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:
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.
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.”
Jakob Dynnes Hansen, CFO
Paul Verbraeken, IR
This press release contains specific forward-looking statements, e.g. statements including terms like believe, assume, expect or similar expressions. Such forward-looking statements are subject to known and unknown risks, uncertainties and other factors which may result in a substantial divergence between the actual results, financial situation, development or performance of the company and those explicitly or implicitly presumed in these statements. Against the background of these uncertainties readers should not place undue reliance on forward-looking statements. The company assumes no responsibility to update forward-looking statements or to adapt them to future events or developments.