Evolva?s EV-077 achieved objectives in first group of patients in Phase IIa trial
Further data to be presented at ESC Congress 2012
Reinach, Switzerland, 17 August 2012 - Evolva Holding SA (SIX:
EVE) today announced top-line results for the first 32 patients
enrolled in the Phase IIa study of its investigational drug,
EV-077, a novel, reversible antagonist of isoprostanes and
prostanoids.
The initial analysis shows promising efficacy data, indicating that
300mg EV-077 given orally twice daily to patients with type 2
diabetes provided anti-platelet activity, reduced exercise-induced
proteinuria and increased forearm blood flow. This was achieved
with only a slight increase in bleeding time. The analysis also
indicated that EV-077 was generally well tolerated, with adverse
events mostly limited to increases in liver enzymes, which were
transient or resolved after discontinuation.
Evaluation of the data of the first 32 patients of the
Proof-of-Concept study was part of the adaptive design agreed with
the German regulatory authority BfArM. Evolva is exploring, in
consultation with BfArM, how to best address the liver enzyme
elevations, for example by using lower doses in the second part of
the study. The initial analysis supports the hypothesis that lower
doses will demonstrate efficacy.
Evolva will present further data in a parallel symposium titled
“EV-077: a novel approach to vascular inflammation” at
the European Society of Cardiology (ESC) Congress 2012 on 28 August
2012, in Munich, Germany. Link:
http://spo.escardio.org/SessionDetails.aspx?id=399515. The
information presented at the symposium will be made available via
Evolva’s website on 29 August, at the same time as
Evolva’s half year results.
Neil Goldsmith, CEO of Evolva, commented “The early efficacy
data are encouraging and seem to underpin the potential of EV-077.
We are in contact with BfArM regarding next steps. We are looking
forward to sharing our data with the scientific and medical
community at the ESC Congress 2012.”
- ends -
About the Phase IIa study
The study is designed to assess to safety, tolerability and
pharmacokinetics of 28 days EV-077 treatment, and its effects on
platelet function, vascular inflammation and oxidative stress in
type II diabetics. It is a single-centre study, conducted in
Germany. The intention is to enrol up to 64 evaluable patients. The
study is randomised, double-blind and placebo-controlled.
Measurements 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).
About Evolva
Evolva’s mission is to discover and provide innovative,
sustainable ingredients for health, nutrition and wellness. Evolva
uses biosynthetic and evolutionary technologies to create and
optimise small molecule compounds and their production routes. We
are active in consumer healthcare and nutrition as well as in
pharma. In both areas we have partnered projects as well as
proprietary programmes. For more information see
www.evolva.com.
Contact Details
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
Posted: August 2012
