Evolva completes Phase I studies with EV-077


July 15, 2011, Evolva Holding SA (SIX: EVE) announced today the completion of a Phase I multiple ascending dose clinical study with an extended release oral formulation of EV-077.


he 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. 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.

Evolva is developing EV-077 for the treatment of complications of diabetes. EV-077 is an oral thromboxane receptor antagonist and thromboxane synthase inhibitor that belongs to a new structural class. 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.

Contact
Evolva Neil Goldsmith, CEO neilg@evolva.com + 41 61 485 2005

Jakob Dynnes Hansen, CFO jakobdh@evolva.com + 41 61 485 2034

Paul Verbraeken, IR + 41 61 485 2035 paulv@evolva.com

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Conclusion of this article: « Evolva completes Phase I studies with EV-077 »

Source: Evolva Holding SA, Press release