Date: 2011-07-15
Type of information:
phase: 1
Announcement: completion of the study
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 study, conducted in Germany, involved 32 volunteers in 4 cohorts in a blinded, placebo controlled, randomised trial. Six individuals in each cohort were treated with increasing doses of EV-077 for 7 days whilst the remaining two received placebo. The aim of the study was to evaluate the safety, kinetic and pharmacodynamic profile of EV-077 given twice daily and to determine the minimal effective and the maximum tolerated dose.
Latest
news: Evolva has announced the completion of a Phase I multiple ascending dose clinical study with an extended release oral formulation of EV-077.Complete inhibition of platelet activation was obtained at the lowest dose tested (120mgs BID) whilst the maximum tolerated dose was 600mgs BID. Further analysis of the data is ongoing. The results will allow Evolva to select a therapeutic dose range for the first Phase IIa clinical trial in patients with Type 2 diabetes. Prior to the just completed multiple ascending dose study Evolva has conducted Phase I single ascending dose and pharmacokinetic studies on EV-077.
Diabetes causes an increased production of prostanoid metabolites which in turn chronically activate the thromboxane receptor in individuals with diabetes. This increases platelet activation and vascular inflammation, with two key clinical consequences: an increased predisposition of diabetics to vascular events and a progressive deterioration in diabetics of renal function. EV-077 can potentially counteract these deleterious events.
