Evolva’s EV-077 achieved objectives in first group of patients in Phase IIa trial

Further data to be presented at ESC Congress 2012

17. Aug 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 –

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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.

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).

Contact Details
Evolva

Neil Goldsmith
CEO
[email protected]
+ 41 61 485 2005
Jakob Dynnes Hansen
CFO
[email protected]
+ 41 61 485 2034
Paul Verbraeken
IR
[email protected]
+ 41 61 485 2035

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.

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