Evolva completes Phase I studies with EV-077
Reinach, Switzerland, 15 July 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.
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.
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.
Evolva’s Chief Medical officer, Dr. Norbert Bender, said:
“The successful completion of the multiple dose escalation
study in healthy volunteers takes us an important step closer to a
Phase IIa proof-of-concept clinical trial in diabetic patients. The
complete inhibition of platelet aggregation already in the lowest
tested dose is indicating that EV-077 efficaciously blocks the
thromboxane receptor in humans and that patients can be treated at
low doses. Later this year we will announce the results of all
Phase I studies carried out with EV-077, and in the fourth quarter
of 2011 we plan to start our Phase IIa program in diabetic
patients.”
- ends –
About Evolva
Evolva is an international, innovative synthetic biology company
with a world-class research platform. Evolva strives to improve
people’s lives by applying its technology and other resources
to the discovery and development of new products and processes that
benefit the health, well-being and financial economy of patients,
consumers and partner companies around the world. Evolva uses
biosynthetic and evolutionary technologies to artificially create
and optimise small molecule compounds and their production routes.
Our approach differs from that of the mainstream in the
pharmaceutical and chemical industries. We have discovery
partnerships ongoing both in pharma and in nutrition. In addition
we have a pipeline of promising compounds aimed at infectious and
cardio-renal indications. For more information visit
www.evolva.com.
Contact Details
Evolva
Neil Goldsmith, CEO Jakob Dynnes Hansen, CFO Paul Verbraeken,
IR
neilg@evolva.com
jakobdh@evolva.com
paulv@evolva.com
+ 41 61 485 2005 + 41 61 485 2034 + 41 61 485 2035
M: Communications
Mary Clark
clark@mcomgroup.com
+44 (0)20 7920 2361
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.
Posted: July 2011
