Date: 2011-11-07
Type of information:
phase: 2a
Announcement: authorization
Company: Evolva (Switzerland)
Product: EV-077
Action mechanism: EV-077 is an oral thromboxane receptor antagonist and thromboxane synthase inhibitor and belongs to a new structural class. Preclinical and early clinical studies indicate the compound has potential as an inhibitor of the effect of isoprostanes and prostanoids on the thromboxane prostanoid receptor.
Disease: complications of diabetes
Therapeutic area: Metabolic diseases
Country: Germany
Trial
details: 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.
Latest
news: Evolva has received regulatory clearance to progress its pharmaceutical compound EV-077 into Phase IIa clinical studies for the treatment of complications of diabetes. Evolva remains on track for Phase IIa data by mid-2012. The company has obtained good interest from several established pharmaceutical companies in the utility of EV-077 in diabetics, and Evolva is confident that the Phase IIa data will provide a good basis for future partnering.
